Healthcare Newsletter

26-09-2021

The National Council of Clinical Establishments urges the government to necessitate oxygen plants in hospitals with over 50 beds

Under the Directorate General of Health Services, Government of India, the National Council for Clinical Establishments recommended ensuring oxygen availability in hospitals and clinical establishm

17-09-2021

Lilly declares lebrikizumab significantly improved skin clearance and itch in moderate-to-severe atopic dermatitis patients

Lebrikizumab provided significant improvements with at least 75% skin clearance in over 50% of the people with moderate-to-severe AD (atopic dermatitis) in Eli Lilly and company's ADvocate 1 and AD

02-09-2021

Asensus Surgical receives FDA approval to boost machine vision capabilities

Asensus Surgical received USFDA’s 510(k) clearance to boost machine vision capabilities on its Intelligent Surgical Unit (ISU).

The said ISU is used for digital laparoscopy with Asens

02-09-2021

Thermo Fisher collaborates with AstraZeneca to create companion diagnostics

Thermo Fisher Scientific’s clinical sequencing unit and AstraZeneca entered a collaboration for multiple years to create next-generation sequencing (NGS)-based companion diagnostics (CDx).

01-09-2021

NCI researchers develop blood tests for early detection of cancer in NF1 patients

Researchers at NCI's (National Cancer Institute) Centre for Cancer Research and Washington University School of Medicine have come up with a blood test to detect cancer early in people with neurofi

01-09-2021

Zymo Research's SafeCollect receives a CE mark

Zymo Research received a CE mark for its novel at-home sample collection kits for sale in the EU (European Union).

The SafeCollect Sample Collection Kits offer customers safety and utility

31-08-2021

FDA approves Zimmer and Canary's smart knee implant

The USFDA (Food and Drug Administration) granted De Novo classification and authorization to Zimmer Biomet and Canary Medical to market the tibial extension for Persona IQ for total knee replacemen

30-08-2021

The Knee Clinic launches Mumbai district’s prime robotic knee replacement center

The Knee Clinic at ACI-Cumballa Hill Hospital launched Mumbai's foremost robotic knee replacement center.

The NAVIO-CORI robotics platform is one of the advanced healthcare innovations of t

28-08-2021

WHO releases rapid communication on renewed guidance for TB management in children and adolescents

The WHO (World Health Organization) Global Tuberculosis Program released a rapid communication on important updates to guidance on TB (tuberculosis) management in children and adolescents. The new

28-08-2021

Molbio Diagnostics to provide near-care diagnostic solutions and change healthcare practices

Molbio Diagnostics aims to transform healthcare practices by providing near-care diagnostic solutions using robust portable platforms and enabling decentralized diagnostics through high-end point-o

26-08-2021

New Respirator masks kill SARS-CoV-2 on contact

Lancaster-based ViraCoat Limited announced the global launch of a new range of antiviral and antimicrobial personal protective equipment (PPE) masks that could kill SARS-CoV-2 and other viruses on

26-08-2021

USPSTF reduces recommended T2D, Prediabetes screening age to 35 years

The USPSTF (United States Preventive Services Task Force) reduced its recommended screening age for type 2 diabetes (T2D) and prediabetes from 40 to 35 years for overweight and obese

26-08-2021

WHO revises BP control guidelines

The WHO (World Health Organization) issued fresh guidelines for blood pressure (BP), recommending 130 as the upper number threshold for starting medicines for anyone with risk factors or a history

25-08-2021

Catalyst OrthoScience showcases imaging IT tool for preoperative planning

Catalyst OrthoScience unveiled an imaging software, Archer 3D Targeting, that aids in preoperative planning for shoulder arthroplasty.

The software developed in collaboration with a 3D-Side

25-08-2021

FDA approves Medtronic’s new TAVR system to treat aortic stenosis

The USFDA approved Medtronic’s latest self-expanding TAVR (transcatheter aortic valve replacement) system to treat symptomatic severe aortic stenosis.

The Evolut FX TAVR system is eas

25-08-2021

The UK Government launches a nationwide antibody testing program

The UK Health Security Agency's new national surveillance program aims to perform antibody tests for adults. It would help improve understanding of immunity against COVID-19 from vaccination and in

24-08-2021

Mackwell Health partners with GE Current for LED UV disinfection tech

Mackwell Health and GE Current announced a collaboration in the field of LED UV disinfection technology. The partnership will spread Current's 365DisInFx UV Technology to the Middle Eastern, Europe

23-08-2021

Abingdon launches BioSure 20-minute result antibody test

Abingdon Health, a global developer and manufacturer of rapid tests, launched the BioSURE COVID-19 IgG Antibody Self Test.

BioSure, UK, is the legal manufacturer of the test that uses a fra

18-08-2021

MHRA (Medicines and Healthcare product Regulatory Agency) approved COVID-19 Vaccine Moderna in 12-17-year olds

The UK’s MHRA approved an extension to the latest consent of the Spikevax vaccine, formerly COVID-19 Vaccine Moderna, that allows its use in individuals aged 12-17 years.

The JCVI (Jo

17-08-2021

Ketto launches a healthcare community app to mark its 9th anniversary

Ketto.org, South East Asia’s leading crowdfunding platform, launched ‘Healthnest,’ a healthcare community app. 

Healthnest is a social community platform that connect

14-08-2021

Mustang Bio signs licensing pact with Mayo Clinic for novel CAR T technology

Mustang Bio, a clinical-stage biopharmaceutical company, declared that the company had implemented an elite license agreement with Mayo Clinic for innovative technology. The technology may reconstr

14-08-2021

The NIH-funded study highlights stark racial disparities in maternal deaths

Ethnic and racial disparities in maternal mortality — deaths about pregnancy or childbirth — in the United States may be greater than previously reported, recommends a study funded by t

10-08-2021

Medtronic introduces a DCB catheter for CAD in Europe

On receiving the CE mark, Medtronic has introduced its DCB (drug-coated balloon) catheter, Prevail, in Europe to treat CAD (coronary artery disease) patients.

Prevail DCB is useful in percu

09-08-2021

The Neuberg Centre for Genomic Medicine observes a surge in lung cancer incidences among women

The Neuberg Centre for Genomic Medicine recorded a rise in lung cancer incidences among women. Smoking remains a principal cause of lung cancer, with a danger of advancing it in smokers vs. non-smo

09-08-2021

PerkinElmer's AlphaLISA kits expand its KRAS oncology drug discovery assays

PerkinElmer announced four new ready-to-use AlphaLISA KRAS kits designed to assist scientists in better understanding complex KRAS protein structures and mutations. It would aid the scientists in i

08-08-2021

MeMed COVID-19 Severity test receives a CE mark

A host response-based technologies specialist, MeMed, received the CE Mark in Europe for its new disease management solution, MeMed COVID-19 Severity.

The test measures multiple proteins fr

07-08-2021

Sanofi’s phase 3 trial analyzing Dupixent to treat chronic spontaneous urticaria meets primary and secondary endpoints

Sanofi declared a pivotal phase 3 trial assessing Dupixent (dupilumab) in patients with moderate-to-severe CSU (chronic spontaneous urticaria), an inflammatory skin disease, met its primary endpoin

07-08-2021

The expert panel suggests a nod to SII for phase 2/3 trials of Covovax for 2-17-year-old kids

An expert panel of India's Central Drug Authority recommended granting permission to SII (Serum Institute of India) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with ce

04-08-2021

Merck declared positive results of Keytruda in combo with chemotherapy to treat patients with mTNBC from the phase 3 KEYNOTE-355 trial

Merck announced positive overall survival (OS) results from the pivotal phase 3 KEYNOTE-355 trial analyzing Keytruda, Merck’s anti-PD-1 therapy, combined with chemotherapy to treat metastatic

03-08-2021

Orthofix Medical introduces fiber bone-graft solution

Orthofix Medical launched its fiberFuse Strip, an advanced demineralized bone-graft solution comprising cancellous bone.

The latest fiberFuse Strip is a preformed bone-graft strip for poste

02-08-2021

Experts state hair loss as one of the most frequently reported syndromes in patients recuperating from Covid-19

According to some experts from the Indraprastha Apollo Hospital, Hair loss is one of the most frequently listed syndromes in patients recovering from Covid-19.

Problems like recurrent skin

02-08-2021

HMD launches next-generation 3-way stop cock, Dispoway

HMD (Hindustan Syringes and Medical Devices), one of the top five manufacturers of syringes and needles worldwide, has introduced Dispoway, a new and improved 3-way stop cock for infusing more than

02-08-2021

Cepheid gets CE-IVD clearance Xpert HIV-1 viral load XC &Xpert HIV-1 Qual XC for HIV-1 tests

Cepheid declared that it had received CE-IVD approval for Xpert HIV-1 Qual XC and Xpert HIV-1 Viral Load XC, next-generation extended-coverage (XC) tests for HIV testing.

Xpert HIV-1 Viral

02-08-2021

Medtronic’s AI algorithms for cardiac monitoring get FDA nod

The USFDA (Food and Drug Administration) approved Medtronic’s two artificial intelligence (AI) algorithms for use with the LINQ II insertable cardiac monitor (ICM).

The AccuRhythm AI

01-08-2021

Abbott launches Jot Dxinsertable cardiac monitors in the US market to detect abnormal heart rhythms.

Abbott announced the US introduction of Jot Dx, the company's newest insertable cardiac monitor (ICM). The Jot Dx ICM provides clinicians and hospitals command of how they control data flow through

30-07-2021

Rajasthan installs the 5th oxygen generator plant in Pilani

To fight any upcoming Covid-19 variants, the Rajasthan government has installed the fifth oxygen generator plant in Pilani in the Jhunjhunu district.

Since early 2020, people are living wit

29-07-2021

Ayush ministry acknowledges research on Ayush medicines to restrict Covid-19 spread

The Union Ayush Ministry directs the States/Union Territories licensing authorities/Drug Controllers to allow Ayush-64 licensed manufacturers under their jurisdiction to include a new indication of

29-07-2021

AstraZeneca's Vaxzevria for Covid 19 showed no increased incidence of thrombosis with thrombocytopenia after the second dose

AstraZeneca's analysis of its Covid-19 vaccine, Vaxzevria, showed no increased incidence of TTS (thrombosis with thrombocytopenia syndrome) after a second dose. Vaxzevria's brand name in India is C

29-07-2021

Vodafone Idea Foundation intends to improve healthcare infrastructure by providing medical supplies to hospitals pan-India

Vodafone Idea Foundation (Vi) has volunteered to strengthen the healthcare infrastructure across India. As a component of its corporate social responsibility (CSR), Vi has distributed critical medi

27-07-2021

Biocon's unit collaborates with Adagio Therapeutics for antibody treatment of Covid-19

Biocon Biologics and Adagio Therapeutics collaborated to advance antibody treatment to prevent and treat COVID-19.

Adagio Therapeutics, U.S., granted an exclusive license to Biocon Biologic

27-07-2021

MolGen announces entrance into the U.S market

MolGen B.V., a single-source supplier of DNA/RNA extraction technology and services for the life sciences and biotechnology, has announced its entrance into the U.S. market with the launch of MolGe

26-07-2021

Cancer Research UK develops urine and blood tests for brain tumors

Scientists at Cancer Research UK have devised tests to identify glioma, a type of brain tumor, from the patient's urine or blood plasma sample.

To aid in easy monitoring, scientists seek wa

26-07-2021

J&J Vision launches a new system for cataract surgery

Johnson & Johnson (J&J) Vision launched its phacoemulsification (phaco) system worldwide. The VERITAS Vision System intends to provide surgeons with improved efficiency and comfort during c

26-07-2021

Wyss Center collaborates with Artiria for cerebral vasospasm therapy

The Wyss Center and Artiria Medical have collaborated to develop a technology that can potentially lower mortality and enhance the quality of life in stroke patients.

Stroke leads to bleedi

25-07-2021

IBM and NanoDx to develop nanoscale sensors for rapid diagnostic testing

NanoDx collaborated with IBM Research to use its metal-oxide semi-conductive (CMOS) compatible nanoscale sensors to boost and extend accurate, rapid testing for various indications.

The com

25-07-2021

Bio-Rad launches COVID & Flu PCR kit

A life science research, and clinical diagnostic product provider, Bio-Rad Laboratories, has launched the "Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD)" for EU markets after CE-IVD mark approval.

25-07-2021

A biochip for coronavirus testing is coming soon

The Research Institute of Rospotrebnadzor has started working on the development of a biochip for COVID-19 testing. 

Rospotrebnadzor published the outcomes of studies of the COVID-19 i

25-07-2021

FDA awards breakthrough device classification to Endologix’s ChEVAS System

The US Food and Drug Administration (FDA) awarded breakthrough device designation to Endologix’s ChEVAS (Chimney EndoVascular Aneurysm Sealing) System for treating abdominal aortic aneurysm (

25-07-2021

DePuy Synthes introduces robotic-assisted knee surgery solution in Australia

Johnson & Johnson's orthopedics company, DePuy Synthes, originated its VELYS Robotic-Assisted Solution for knee replacement surgery in Australia.

VELYS is to be used with the company's

25-07-2021

ROSA Knee System presents a highly customized surgery experience

Patients experiencing total knee replacement at Mater Private Network in Cork could benefit from faster recovery times and an extra customized overall experience, introducing the new ROSA Knee Syst

25-07-2021

Oysters recalled among Washington's largest-ever Vibrio outbreak

Washington state recalled live oysters harvested from the Samish Bay growing area in the Puget Sound area. The recall is because of multiple Vibrio parahaemolyticus illnesses linked with oysters ha

25-07-2021

Phoenix launches a new full-body cancer screening imaging service

Phoenix Hospital Group, UK, has launched a new full-body cancer screening imaging service to detect cancer in its early stages.  

The hospital’s outpatient consulting and im

25-07-2021

IQVIA collaborates with BREATHE to improve respiratory health outcomes

IQVIA- analytics, technology solutions, and clinical research services provider, announced a new collaboration with BREATHE – a Health Data Research Hub for Respiratory Health.

The pa

25-07-2021

Acute COVID app launched to assist redeployed NHS staff

Chelsea and Westminster Hospital NHS Foundation Trust and its charity CW+ have launched the Acute COVID app, co-developed with Imagineear Health to support NHS staff redeployed to care for COVID-19

24-07-2021

Intelligent Fingerprinting creates saliva-based Covid-19 antigen test

Intelligent Fingerprinting, UK, has created a user-friendly, saliva-based lateral flow VSS-GP test for rapid SARS-CoV-2 antigen detection.

The current Covid-19 tests require invasive nose a

24-07-2021

NPPA caps the price for five medical devices for affordable and better COVID-19 management

Because of the evolving COVID-19 pandemic and the continuing demand for medical devices, the National Pharmaceutical Pricing Authority (NPPA) is restricting the trade margin for five medical device

23-07-2021

ISTAR Medical gets an FDA nod to initiate a trial of MINIject for glaucoma

iSTAR Medical received IDE (investigational device exemption) from the USFDA (Food and Drug Administration) to begin a clinical trial of its MINIject, a minimally invasive implant for glaucoma surg

23-07-2021

NuVasive holds US sales of scoliosis devices amid biocompatibility concerns

NuVasive is permanently stopping US sales of its MAGEC 1.5 and 2 scoliosis medical devices amid biocompatibility concerns. The move comes after the FDA's warning of potential mechanical failures an

23-07-2021

Dexcom wins FDA approval for real-time APIs, allowing third-party developers access to CGM data

The FDA approved Dexcom's Partner Web Application Programming Interfaces (APIs), allowing the third-party developers to access the continuous glucose monitoring (CGM) information of Dexcom users.

23-07-2021

Canon Medical and Cleerly to produce heart disease solutions

Canon Medical Systems, USA, has subscribed to a decisive collaboration with Cleerly to facilitate simple and effective cardiac computed tomography (CT) to grant a new standard of care for heart ail

23-07-2021

The recalled Philips sleep apnea ventilator was classified as Class I by FDA

The FDA officially labeled Philips' recall of sleep apnea and ventilator devices a Class I event, about one month after the company's announcement. The agency put out two separate notices Thursday

23-07-2021

NuVasive introduces 3D-printed porous titanium implant for spine surgery

NuVasive launched a new 3D-printed porous titanium implant, Modulus ALIF, for anterior lumbar interbody fusion (ALIF) procedures in certain countries.

The device strengthens the company&rsq

22-07-2021

Scottish consortium to use AR to upskill surgeons on 3D-printed models

A Scottish syndicate is launching an AR (augmented reality) tool to help train surgeons on hyper-real 3D-printed models of human organs.

The software will guide trainee surgeons while

22-07-2021

New screening service to recognize children at risk of heart disease

Over the next couple of years, 30,000 children across England will be evaluated using a heel prick blood test for a ‘faulty gene’ which causes familial hypercholesterolemia (FH).

<

22-07-2021

B-Secur partners with Texas Instruments for ECG/EKG monitoring

B-Secur has launched an ECG (electrocardiogram) solution based on the TI's (Texas Instruments) AFE4950 analogue front end for photoplethysmography (PPG). The new ECG sensing will accelerate the des

22-07-2021

Omniscient’s brain mapping platform receives FDA grants 510(k) clearance

Quicktome, Omniscient Neurotechnology’s (o8t) digital brain mapping platform, received the USFDA (Food and Drug Administration) 510(k) clearance for neurosurgery.

A neurosurgical plan

22-07-2021

Philips’ IVC filter removal device receives FDA breakthrough status

The USFDA (Food and Drug Administration) granted breakthrough device designation to Royal Philips’ laser-assisted IVC (inferior vena cava) filter removal device.

The device helps in a

22-07-2021

Boston Scientific’s LAAC device reduces ischemic stroke in a trial

Boston Scientific reported positive data from the PINNACLE FLX clinical trial of its WATCHMAN FLX LAAC (Left Atrial Appendage Closure) device in NVAF (non-valvular atrial fibrillation) patients.

21-07-2021

Quibim joins a business alliance to develop a total-body PET scanner

Quibim has entered a temporary business association (TBA) with molecular imaging companies to develop a total-body PET (positron emission tomography) /CT (computed tomography) scanner for simultane

21-07-2021

BD's Velano acquisition to enable needle-free blood draw

Becton, Dickinson, and Company (BD) plan to introduce a 'One-Stick Hospital Stay' approach by using its expertise in blood collection and vascular access solutions.

The company will us

21-07-2021

NeuroMetrix’s fibromyalgia device gets FDA breakthrough status

The USFDA (Food and Drug Administration) has granted breakthrough device designation to NeuroMetrix’s Quell device to treat fibromyalgia symptoms in adults.

A transcutaneous electrica

21-07-2021

Miiskin launches an AR-powered new mole sizing feature

Miiskin, a digital health app, which helps people track modifications in their skin, including existing and new moles, has come up with a new mole sizing feature that allows patients to check chang

21-07-2021

Unilabs and Ibex collaborate to implement an AI cancer platform in Europe

Unilabs, a diagnostic services provider, and Ibex Medical Analytics, a specialist in AI-powered cancer diagnostics, have collaborated to implement Ibex's AI platform in Europe.

Starting wit

21-07-2021

Owlstone Medical declares findings of mask filter alternative to NPS

Owlstone Medical, a Breath Biopsy specialist for early disease detection and precision medicine applications, has published peer-reviewed research in Nature Scientific Reports. The paper examines t

21-07-2021

T-diagnostic centers offer free medical testing and diagnostic services to the public

The T-diagnostic centers, launched in Telangana, offer free medical testing and other disease diagnostic services to the public and relieve the poor from the ever-rising healthcare costs in the sta

17-07-2021

Fear of the third Covid-19 wave forces the Centre to take advanced steps to bridge gaps in the healthcare sector

As experts from IMA (Indian Medical Association) and various State and Central government agencies not denying a possible third Covid-19 wave in India, the Union government is working on a comprehe

16-07-2021

Medtech enterprise TestCard introduced a new ‘Test and Treat’ service utilizing its at-home UTI test kit in partnership with Dears Pharmacy

As per experts, the waiting times for UTI treatment can be within 3-5 days, and undiagnosed UTIs have risen during the pandemic due to the limited access to GP appointments.

Now with this n

16-07-2021

Evoke Pharma introduces a patient and physician experience program for Gimoti, nasal spray for acute and recurrent DGP

Evoke Pharma, a specialty pharmaceutical company,

announced some additional marketing initiatives focusing on launching a patient and physician experience program for Gimoti, the company&rs

16-07-2021

A molecular, point-of-care Covid-19 test from Cue Health receives CDSCO approval

Cue Health, a healthcare technology company, announced receiving regulatory approval from CDSCO (Central Drugs Standard Control Organization) for its Cue Covid-19 Test for professional point-of-car

14-07-2021

Hologic obtains CE mark for saliva specimens on COVID-19 assay

Hologic has received a CE Mark for Aptima SARS-CoV-2 assay in Europe to utilize saliva samples. The test is a molecular diagnostic assay that identifies the pathogen's genetic material causing COVI

14-07-2021

NHS to finance ‘skin snaps’ and rapid tests for same-day cancer diagnosis

The NHS (National Health Service) in the UK has announced an investment of £20m to hasten the rollout of ‘skin snaps’ and other rapid tests for same-day cancer diagnoses to improv

14-07-2021

BPR Medical's medical gas solutions receive MDSAP certification

UK-based independent manufacturer of medical gas products, BPR Medical, received MDSAP (Medical Device Single Audit Program) certification for its medical gas solutions. 

Only a few me

14-07-2021

FDA approves Stryker’s biodegradable subacromial balloon implant

The USFDA (Food and Drug Administration) has approved Stryker’s InSpace balloon implant for arthroscopic therapy of MIRCTs (massive irreparable rotator cuff tears) for sustained improvements

14-07-2021

Seegene launches a new test to distinguish SARS-CoV-2 variants

South Korea-based biotech Seegene has introduced a new multiplex PCR (polymerase chain reaction) test to screen for six emerging SARS-CoV-2 variants, including the Delta and Delta Plus variants.

13-07-2021

WHO releases the latest guidelines on human genome editing for the advancement of public health

Two new companion reports published by the WHO (World Health Organization) provide the first global recommendations to help establish human genome editing as a tool for public health, emphasizing s

13-07-2021

IMA urges the state governments to toughen the Covid-19 protocol for the third wave

The IMA (Indian Medical Association) has urged the state governments not to let off the guard against Covid-19 and control mass gatherings in the state in the wake of a possible third wave.

13-07-2021

WHO’s chief scientist cautions against the mixing of Covid-19 vaccines from different manufacturers

WHO (World Health Organisation) chief scientist Soumya Swaminathan has cautioned against mixing and matching Covid-19 vaccines from various manufacturers, stating that it is a dangerous trend that

13-07-2021

Ayush Ministry introduces Ayurveda dataset on CTRI portal

The Union Ministry of Ayush launched the Ayurveda dataset on the Clinical Trials Registry-India (CTRI) gateway. The move is a significant step towards global visibility for Ayurveda-based clinical

13-07-2021

WHO includes interleukin-6 receptor blockers for Covid-19 patient care guidelines

The WHO (World Health Organization) reformed its Covid-19 patient care guidelines to include interleukin-6 receptor blockers as a class of lifesaving medicines in severely or critically ill patient

13-07-2021

Philips partners with NICO.LAB to enhance stroke care

Royal Philips inked a strong collaboration dealing with a MedTech stroke care company, NICO.LAB to intensify results in stroke patients.

The contract will complement the extensive stroke ab

13-07-2021

GE Healthcare and SOPHiA ally to develop AI-driven cancer solutions

GE Healthcare and SOPHiA GENETICS inked a letter of intent to operate together on targeting and coordinating therapies that can accommodate unique patient’s genomic profiles and cancer types.

13-07-2021

Thermo Fisher and Ortho Clinical associate to provide quality control products

Thermo Fisher Scientific has partnered with Ortho Clinical Diagnostics to supply its MAS Quality Controls and LabLink xL Quality Assurance Software to be used with the latter’s VITROS analyze

13-07-2021

PocDoc and PATH associate in a bid to eradicate polio

PocDoc and PATH will produce an app-based digital reader for primary immunodeficiency diseases (PID) to help scale PID rapid testing and support the rollout of polio vaccinations across the world,

13-07-2021

Siemens’ MAGNETOM Free.Max MR scanner gets FDA approval

The USFDA (Food and Drug Administration) approved Siemens Healthineers’ MAGNETOM Free.Max, a High-V MR (magnetic resonance) scanner.

The device merges a 0.55 Tesla field strength with

13-07-2021

Quidel obtains a CE mark for a multiplex analyzer and a respiratory viral panel

Quidel has obtained a CE mark for its Savanna multiplex molecular analyzer and Savanna Respiratory Viral Panel-4 (RVP4) Assay.

The approval allows marketing and sale of the Savanna system i

12-07-2021

EMA states potential link to very rare cases of myocarditis and pericarditis following vaccination with Covid-19 Vaccines Comirnaty & Spikevax

EMA’s safety committee (PRAC) announced that myocarditis and pericarditis could emerge in rare instances following Covid-19 Vaccines Comirnaty and Spikevax (previously Covid-19 Vaccine Modern

12-07-2021

Launch of Panbio Covid-19 antigen self-test in India: Abbott

Abbott declared the launch of Panbio Covid-19 antigen self-test to detect the SARS-CoV-2 virus in grown-ups and children with or without signs. In line with the current ICMR guidelines on self-use,

12-07-2021

SDSOS produces a battery-operated reusable mask to shield from airborne human pathogens

Sunandan Divatia School of Science (SDSOS), Mumbai, originated a battery-operated reusable mask to protect from airborne human pathogens.

The technology is transferred to Mumbai-based Milto

12-07-2021

Pluss Advanced Technologies (PLUSS) to render transport and storage solution to Dr. Reddy’s for Sputnik V vaccine

PLUSS will supply its Celsure Covid Suraksha box to Dr. Reddy’s Laboratories Ltd, for optimal temperature-controlled transportation and storage for the Sputnik V vaccine, in India.

PL

12-07-2021

Morphic declares positive results from phase 1 trial of MORF-057 for inflammatory bowel disease

Morphic Therapeutic announced positive results from its full phase 1 clinical trial for MORF-057, an oral small-molecule inhibitor of the a4ß7 integrin in development to treat inflammatory bo

12-07-2021

An app that could reduce the post-surgery complication rates to halve launched

Digital therapeutics pioneer my mhealth has declared the launch of its latest app, myOp, which can halve post-surgery complication rates and better recovery times for even the greatest-risk patient

10-07-2021

Philips and Spanish CNIC to generate cardiac MR imaging protocol

Royal Philips has partnered with the Spanish National Center for Cardiovascular Research (CNIC) to create a new cardiac MRI (magnetic resonance imaging) technique.

Named "ESSOS" (Enhanced S

10-07-2021

Viz.ai obtains a CE mark for AI-based stroke care software

Viz.ai got a CE mark to sell "Viz LVO," an artificial intelligence (AI)-driven stroke care software.

The clinical data reveals that software can coordinate stroke care, reduce treatment tim

10-07-2021

Qiagen’s NeuMoDxHAdV quant assay gets European CE-IVD label to identify human adenovirus infections

Qiagen declared that its NeuMoDxHAdV Quant Assay to identify and quantify human adenovirus (HAdV) DNA had obtained CE-IVD certification for the European Union and additional countries that allow th

10-07-2021

Blackfrog Technologies develops compact refrigeration device ‘Emvolio’ for carrying vaccines

The Blackfrog Technologies, a startup supported by the Department of Biotechnology-Biotechnology Industry Research Assistance Council (DBT-BIRAC), has developed Emvolio. This portable, battery-oper

10-07-2021

Philips and Cognizant collaborate to launch digital health solutions for providers, researchers, and patients

Royal Philips and Cognizant announced a collaboration to develop end-to-end digital health solutions to enable life sciences companies and healthcare organizations to accelerate clinical trials and

10-07-2021

The Government urged to prioritize NHS imaging services improvements.

The PHSO (Parliamentary and Health Service Ombudsman) has

written to the Government urging it to prioritize improvements to NHS (National Health Services) imaging services as part of the he

10-07-2021

Quidel COVID-19 PCR recall entitled Class I by FDA due to false-negative risk

Quidel obtained emergency use authorization for its Lyra assay on March 17 of last year, presenting it as one of the primary companies to bring a SARS-CoV-2 test to market in the U.S. A rapid antig

10-07-2021

FDA awards breakthrough device rank to Hyalex’s cartilage system

The US Food and Drug Administration (FDA) granted breakthrough device designation to Hyalex Orthopaedics’ cartilage system for fixing cartilage deformities.

The HYALEX Cartilage Syste

10-07-2021

FDA approves Natural Cycles app for birth control wearable

Natural Cycles, the novel FDA-cleared birth control app, has received new FDA clearance to revise its labeling and expand the types of third-party thermometers, including consumer wearable already

10-07-2021

Test detecting COVID-19 within 20 seconds undergoes MHRA registration

A pathogens diagnostic device able to detect SARS-CoV-2 within 20 seconds, SpectraLIT, is undergoing MHRA registration and may shortly be available in the UK.

The device uses mass spectrome

10-07-2021

QuantuMDx launches Q-POC, a rapid PCR system

UK-based developer, QuantuMDx, launched Q-POC - a rapid, PCR point of care diagnostic system. Q-POC received a CE-IVD mark under the In Vitro Diagnostics Directive (98/79/EC), enabling its use in E

10-07-2021

FDA labels Medtronic's recall of unsterilized angiography guidewires as Class I

Medtronic recalled 54,997 guidewire components used during angiography to place catheters into the vascular system for sterilization issues before being shipped to hospitals.

FDA

10-07-2021

AbbVie, Pfizer, and Biogen collaborate to create the world's largest browsable resource linking rare protein-coding genetic variants to human health and disease

Access to the world's largest browsable resource linking rare protein-coding genetic varia

10-07-2021

WHO's new guidelines include Roche's Cobas MTB & Cobas MTB-RIF/INH tests to detect TB and drug-resistant TB

Roche announced the inclusion of Cobas MTB and Cobas MTB-RIF/INH tests used on the Cobas 6800/8800 Systems to detect tuberculosis (TB) and drug-resistant TB. 

The WHO (World Health Org

09-07-2021

FDA validates AliveCor’s ECG device for QTc interval measurement

The US Food and Drug Administration (FDA) awarded 510(k) approval to AliveCor’s electrocardiogram (ECG) device, KardiaMobile 6L, for the measurement of QTc interval in patients by healthcare

09-07-2021

FDA signals biocompatibility issues linked to NuVasive's Precice devices

FDA signaled healthcare providers regarding likely biocompatibility concerns related to NuVasive's stainless steel and titanium Precice orthopaedic appliances. The machines are used to extend the l

09-07-2021

Merck and Innervia collaborate to develop bioelectronic devices

Merck KGaA, Darmstadt, Germany (Merck) collaborated with Innervia Bioelectronics to jointly develop graphene-based bioelectronic vagus nerve treatments for severe chronic diseases.

The coll

07-07-2021

FDA awards EUA to BioGX’s direct sample RT-PCR Covid-19 test

The US Food and Drug Administration has awarded Emergency Use Authorisation (EUA) to BioGX’s direct sample addition Xfree COVID-19 reverse transcription-polymerase chain reaction (RT-PCR) tes

07-07-2021

CDSCO demands Philips India to discontinue continuous & non-continuous ventilators

The Central Drugs Standard Control Organisation (CDSCO) medical devices and diagnostics division ordered Philips India Limited to discontinue continuous and non-continuous ventilators because of so

06-07-2021

Vivalink introduces an enhanced ECG monitor

Vivalink, a provider of coupled healthcare solutions, has originated an afresh enhanced temperature and cardiac electrocardiogram (ECG) monitor.

The new temperature monitor constituted an o

05-07-2021

Front Line receives FDA approval for COBRA-OS device

The FDA (Food and Drug Administration) approved Control of Bleeding, Resuscitation, Arterial Occlusion System (COBRA-OS) from Front Line Medical Technologies.

The COBRA-OS is the first 4 Fr

05-07-2021

Novacyt plans to launch a couple of new lateral flow tests

The clinical diagnostics specialist, Novacyt, is launching two PathFlow COVID-19 antigen lateral flow tests (LFTs) to bolster its COVID-19 portfolio and to pursue new market opportunities, especial

05-07-2021

Abbott's Panbio Self-Test to detect the Covid-19 virus receives a CE mark

Abbott's Panbio COVID-19 Antigen Self-Test received a CE mark. Panbio aims to identify the SARS-CoV-2 virus in adults and children with or without symptoms. The CE mark allows over-the-counter sale

05-07-2021

The US FDA grants pre-market approval to Abiomed's heart pump

Abiomed's Impella RP with SmartAssist got pre-market approval (PMA) from US FDA (Food and Drug Administration). Impella RP is a heart pump that aims to treat acute right heart failure. 

<

03-07-2021

Pregnant women now eligible for Covid vaccination

Pregnant women in India are now qualified to get inoculated against Covid, with the Union Health Ministry on 2 July 2021 granting consent based on the advice of the National Technical Advisory Grou

26-06-2021

FDA adds warnings regarding rare heart inflammation to Pfizer, Moderna COVID shots

The US drug regulator recently appended a warning to the literature that accompanies Pfizer Inc BioNTech and Moderna Covid-19 vaccine shots to intimate the rare risk of heart inflammation after its

26-06-2021

Gilead declares positive interim results from phase 2b and phase 3 trials of Hepcludex to treat chronic hepatitis delta virus

Gilead Sciences stated interim results from the phase 2b and 3 clinical trials assessing the first-in-class entry inhibitor Hepcludex (bulevirtide) to treat chronic HDV (hepatitis delta virus). Con

25-06-2021

India's first AI-enabled smart virtual nutrition mentor app 'Fitza' originated in the market

Fitza, a pioneer in the digital fitness market; a one-of-a-kind mobile application to touch people's experiences by holistic health and nutritional well-being, leveraging advanced technology. The a

25-06-2021

SP introduces SP Hull LyoStar 4.0 R&D freeze dryer to intensify business in drug development

SP Industries, Inc. (SP) declared the launch of its SP Hull LyoStar 4.0 R&D and process development freeze dryer devised and developed to improve the market of biopharmaceutical products, such

25-06-2021

J&J Vision launches TECNIS Synergy & TECNIS Synergy Toric II PC-IOLS in the US & Canada for cataract patients

Johnson & Johnson Vision declared the availability of TECNIS Synergy and TECNIS Synergy Toric II IOLs in the US and Canada. These next-generation PC-IOLs blend the extensive depth of focus and

24-06-2021

Wipro GE Healthcare commences local manufacturing of its Versana Ultrasound series in India

Wipro GE Healthcare intensified its local capacity to manufacture a wide variety of Versana products in India. The initiative is a part of the company’s plan to extend localization and encour

24-06-2021

Innovent's phase 3 ORIENT-15 study of sintilimab in combo with chemotherapy meets primary endpoints for unresectable, locally advanced recurrent or metastatic ESCC.

Innovent Biologics declared that the phase 3 ORIENT-15 study met the predefined overall survival primary endpoint. ORIENT-15 is a randomized, double-blind, global, multi-center clinical study asses

24-06-2021

Experts recommend approaches to do work from home without hurting your back during the Covid-19 pandemic

Specialists have proposed measures to do work from home necessitated by the Covid-19 pandemic without harming your back. Back pain is induced by work-related stress as well as work-related physical

24-06-2021

Max@Home links up NephroPlus to start home hemodialysis services

Max Healthcare's Max@Home service has partnered with NephroPlus to begin a novel initiative to give patients dialysis services at their doorsteps.

This unprecedented partnership brings both

24-06-2021

Novartis, Hewlett Packard Enterprise partnered to expedite the use of data & digital technologies to reimagining global health

Novartis and Hewlett Packard Enterprise (HPE) declared a partnership that aims to stimulate the data and digital technologies' use within Novartis to reimagine global health and better access to he

23-06-2021

Merck's phase 3 KEYNOTE-826 trial of Keytruda in combo with platinum-based chemotherapy with or without bevacizumab to treat cervical cancer patients meets primary endpoints.

Merck, known as MSD also, declared that the pivotal phase 3 KEYNOTE-826 trial analyzing Keytruda, Merck's anti-PD-1 therapy, in combo with platinum-based chemotherapy (cisplatin plus paclitaxel or

23-06-2021

Nordic Nanovector declares positive results from LYMRIT 37-05 phase 1 trial of Betalutin for r/r diffuse large B-cell lymphoma

Nordic Nanovector proclaimed prompting preliminary results from the LYMRIT 37-05 phase 1 trial investigating Betalutin (177Lu lilotomab satetraxetan) for relapsed/refractory diffuse large B-cell ly

23-06-2021

QIAGEN launches QIAprep& CRISPR Kit and CRISPR Q-primer solutions for speedy and simplified investigation of gene-editing examinations

QIAGEN declared the launch of QIAprep&amp CRISPR Kit and CRISPR Q-Primer Solutions that enable researchers to examine edited genetic material with unmatched pace and competence to ascertain how

23-06-2021

Thermo Fisher launches CE-IVD labeled TaqPath Covid-19 swift PCR combo kit 2.0

Thermo Fisher Scientific declared the introduction of a novel CE-IVD marked Covid-19 test. The TaqPath Covid-19 Fast PCR Combo Kit 2.0 extends Thermo Fisher's series of high-precision tests to dete

22-06-2021

Sensome’s Clotild Smart Guidewire system to treat ischemic stroke: US FDA breakthrough therapy status

Sensome declared that the Center for Devices and Radiological Health had awarded it a Breakthrough Device designation of the Food and Drug Administration (FDA) for it

22-06-2021

Avacta signs distribution deal with Calibre Scientific for AffiDX SARS-CoV-2 antigen lateral flow test in UK and EEA

Avacta Group declares a non-exclusive distribution agreement with Calibre Scientific for Avacta's AffiDX SARS-CoV-2 antigen lateral flow test for licensed use in the UK and European Economic Area (

22-06-2021

Algorithmic Biologics for gold-standard RT-qPCR test, Tapestry: gets DCGI nod

Algorithmic Biologics, a Bengaluru-based deep-tech startup producing algorithmic innovations to molecular analysis, received the Drugs Controller General of India (DCGI) approval for commercial use

22-06-2021

Implandata’s Eyemate-SC biosensor for distant glaucoma care gets CE marking

Implandata Ophthalmic Products has declared that its Eyemate-SC biosensor has received CE Mark. This tool is used in association with the breakthrough Eyemate system for digitally-enabled remote gl

21-06-2021

Launches AI face recognition temperature screening product for early isolation of infected individuals: Globus Infocom

Globus Infocom has recently inaugurated its latest AI face identification temperature screening commodity for the initial separation of infected people. It also has an access controller arrangement

21-06-2021

Logix Smart SARS-CoV-2 Direct Saliva test obtains CE marking: Co-Diagnostics

Co-Diagnostics, Inc. declared that its Logix Smart SARS-CoV-2 DS (Direct Saliva) had received regulatory authorization to be traded as an in vitro diagnostic (IVD) for the Covid-19 diagnosis in mar

21-06-2021

New Light Technique Could Change Imaging

A trio of scientists from the University of Exeter has uncovered a novel approach to manage the light that the way has scrambled through a single hair-thin strand of optical fibers. These ultra-thi

19-06-2021

Smart Meter launches cellular-connected body weight scale: iScale

Smart Meter, one of the leads in cellular-enabled distant patient monitoring data and tools, declared the introduction of iScale, a cellular-connected body weight scale. This extension extends its

19-06-2021

Bayer's Astepro allergy nasal spray for respiratory allergies in the US: US FDA approval

Bayer's Astepro Allergy (Azelastine HCI .15%) got the US Food and Drug Administration (FDA) had approval as an OTC (over-the-counter) product for the temporary relief of runny nose, sneezing, nasal

19-06-2021

Researchers devised a device to diagnose pregnancy complications by monitoring the oxygen level of the placenta: NIH

Scientists at the NIH (National Institutes of Health) have produced a model tool that could probably diagnose pregnancy complexities by watching the oxygen level of the placenta. The equipment tran

18-06-2021

Phase 2 TANGO study of gosuranemab fails to meet primary efficacy endpoint to treat Alzheimer's disease: Biogen

Biogen declared topline conclusions from its phase 2 TANGO study of gosuranemab (BIIB092), an investigational anti-tau antibody evaluated as a potential therapy for Alzheimer's.

Gosuranemab

18-06-2021

UK extends EUA (Exceptional Use Authorisation) for Innova’s Covid-19 rapid test amid FDA refusal

The US FDA alerted the public against the use of Innova’s Covid-19 test, citing health hazards.

The UK MHRA (Medicines and Healthcare products Regulatory Agency) has extended the EUA

17-06-2021

Positive results of phase 3 RECOVERY trial of REGEN-COV to treat patients hospitalized with severe Covid-19: Regeneron Pharma

Regeneron Pharmaceuticals declared positive results from the largest trial assessing monoclonal antibody therapy in patients hospitalized with critical Covid-19. The UK RECOVERY trial discovered th

17-06-2021

Phase III STORM CHASER trial of AZD7442 did not meet the primary endpoint for prevention of symptomatic Covid-19: AstraZeneca

AstraZeneca declared results from the STORM CHASER trial assessing the safety and efficacy of AZD7442, a long-acting antibody (LAAB) combination, for prevention of symptomatic Covid-19 in participa

17-06-2021

Vuram introduced the live tracking app 'Trackable' for Covid vaccine allocation

Vuram has originated an innovative app to trace Covid essentials such as vaccines, PPE, oxygen cylinders, and masks. Trackable is the first of its kind Appian live tracking app, and Vuram's team be

17-06-2021

Gait deficit device treatment for MS patients: FDA authorization

Helius Medical Technologies and Cambridge Consultants, part of Capgemini, declared that a device - Portable Neuromodulation Stimulator (PoNS), designed for short-term treatment of gait deficit due

17-06-2021

Medtronic's HeartWare HVAD pump recalls, and the declaration to exit

Medtronic abruptly removed its HeartWare Heart Ventricular Assist Device pump system from the market after a range of Class I recalls in 2021 and reports of patient harms and deaths associated with

16-06-2021

Medtronic launches Micra AV, the world's smallest pacemaker with AV synchrony to treat heart block in patients in India

India Medtronic Private Limited, a wholly-owned subsidiary of Medtronic plc, announced the launch of Micra AV - a miniaturized, fully self-contained pacemaker that delivers advanced pacing technolo

16-06-2021

Phase 3 STAR study of timrepigene emparvovec did not meet the primary endpoint to treat choroideremia: Biogen

Biogen declared topline results of the timrepigene emparvovec (BIIB111/AAV2-REP1), an investigational gene therapy for the potential treatment of choroideremia from the phase 3 STAR study. The stud

16-06-2021

Game-changing" antibody test can identify exposure to new variants

Antibody tests that can recognize whether people have been exposed to new variants (known as the Alpha and Delta variants) of COVID-19 have been produced by the University of Aberdeen, collaboratin

15-06-2021

Phase III trial of regdanvimab (anti-Covid-19 monoclonal antibody treatment candidate) meets all primary and secondary endpoints: Celltrion

Celltrion Group declared top-line efficacy and safety data from the global phase III clinical trial, illustrating that anti-Covid-19 monoclonal antibody treatment candidates, regdanvimab (CT-P59),

15-06-2021

Circle CVI and DiA Imaging collaborate to deliver AI-based all-in-one cardiac imaging solutions

DiA Imaging Analysis Ltd., and Circle Cardiovascular Imaging Inc., declared a multi-year

15-06-2021

Launch of Amplatzer Piccolo Occluder device in India for treatment of premature babies and newborns: Abbott

Abbott introduced its Amplatzer Piccolo Occluder in India, the world's first medical devi

15-06-2021

Avacta lateral flow test registered in EU

Avacta has obtained notification of registering its AffiDX SARS-CoV-2 antigen lateral flow test in the EU, enabling the company to place the product on the market in all 27 countries for acknowledg

14-06-2021

Health risks cause Philips to recall sleep and respiratory care products

Royal Philips voluntarily recalled breathing devices and ventilators after discovering possible health risks linked to the PE-PUR (polyester-based polyurethane) sound abatement foam used in them.

14-06-2021

Verily fails to get FDA approval for its wrist-worn Parkinson's clinical trial device

FDA has rejected Verily's (Google's sibling company) request to use a wrist-worn wearable device that aims to trace changes in the motor symptoms of clinical trial patients with Parkinson's disease

14-06-2021

Medtronic receives FDA approval for a recharge-free neurostimulator

Medtronic received U.S. Food and Drug Administration (FDA) approval for its recharge-free implantable neurostimulator (INS), Vanta. It is a device with an optimized life of up to 11 years.

26-05-2021

Ibex Medical’s AI breast cancer solution receives CE mark

Ibex Medical Analytics, an AI-powered cancer diagnostics firm, has received the CE mark for the Galen Breast solution to support pathologists in detecting various types of breast cancer. 

26-05-2021

Quest Diagnostics collaborates with Paige to develop cancer diagnostics

Quest Diagnostics and Paige have collaborated to develop software products leveraging AI (artificial intelligence) to enhance and expedite the pathologic diagnoses of cancer and various other disea

26-05-2021

Photonics is planning to reinvent the Apple Watch for health tracking

Rockley Photonics plans to develop a technology that enables the Apple Watch to track blood glucose levels non-invasively.

All clients of Rockley Photonics, like Apple Inc., are developing

25-05-2021

FDA clears two endoscopes that avoid reprocessing

FDA approved two new single-use, disposable endoscopes, less than two months after again cautioning healthcare providers to be aware of contamination issues and infection risks tied to versions of

25-05-2021

New research proves kangaroo mother care started promptly after childbirth, critical for saving lives

The outcomes of a new clinical trial published in the NEJM (New England Journal of Medicine) reveal that immediate kangaroo mother care started soon after a preterm or low birthweight baby is born

25-05-2021

Fitterfly introduces a post-Covid recovery program for diabetic people

Fitterfly, a digital therapeutics company, launched a post-Covid recovery program for people with diabetes. During this Covid pandemic, the worst affected are people with comorbidities like diabete

25-05-2021

Brains Hospital’s Allovedas introduces post-Covid rehabilitation to overcome associated complexities

Allovedas, a unit of Brains Hospital, is a comprehensive, integrated rehabilitation center that introduced an exclusive program for post-Covid rehabilitation. The initiative termed ‘Bounce Ba

24-05-2021

Migration risk causes recall of venous stents by Boston Scientific

Boston Scientific is recalling all Vici RDS and Vici SDS venous stent systems sold over the last 30 months because of 17 complaints about the products.

Users complained that the devices mig

24-05-2021

HSA Singapore gives provisional approval to Breathonix's Covid-19 breath test

Singapore's Health Sciences Authority (HSA) provisionally authorized Breathonix's BreFence Go COVID-19 Breath Test System for accurate disease identification in a minute. Breathonix, a spin-off fir

24-05-2021

EmpowerDX at-home Covid-19 test for children receives EUA from FDA

The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the at-home Covid-19 testing kit for children aged three years and above by Eurofins Scientific subsidiar

24-05-2021

Phase 3 RATIONALE 309 trial of BeiGene’s tislelizumab combined with chemotherapy to treat recurrent or metastatic NPC meets the initial endpoint

BeiGene Ltd. declared that the phase 3 RATIONALE 309 trial of its anti-PD-1 antibody tislelizumab together with gemcitabine and cisplatin versus placebo combined with gemcitabine, and cisplatin as

24-05-2021

IISc incubated PathShodh receives DCGI approval for the ELISA Covid-19 test kit after THSTI validation

PathShodh Healthcare, a start-up nurtured at the Society for Innovation and Development (SID), IISc (Indian Institute of Science), received the license to manufacture the test for sale of its semi-

24-05-2021

NABL mandates QR codes on test reports & calibration certificates to prevent manipulation

The NABL (National Accreditation Board for Testing and Calibration Laboratories) has mandated QR codes on the test reports and calibration certificates to check the manipulation of test results and

24-05-2021

Ortho Clinical Diagnostics launches quantitative Covid-19 IgG spike antibody test and nucleocapsid antibody test to help distinguish the cause of antibody response

Ortho Clinical Diagnostics launched the first quantitative Covid-19 IgG antibody test in addition to a complete Covid-19 nucleocapsid antibody test.

Ortho is the first company offering labo

24-05-2021

DCAL and BUSM announce successful results for a study that uncovers treatment for vitamin D deficiency

India-based DCAL (Dishman Carbogen Amcis Limited), the pharmaceutical industry's global outsourcing partner, announced the results of a new study providing critical insights into the treatment of v

24-05-2021

To help hospitals treat both Covid and non-Covid patients, KareXpert launches a virtual care platform

KareXpert, one of India's most agile growing healthcare technology companies, launched its cloud-based virtual care platform for hospitals and other healthcare institutions to treat Covid and non-C

22-05-2021

Merck declares PNEU-DIRECTION & PNEU-PLAN phase 3 pediatric studies for an investigational 15-valent pneumococcal conjugate vaccine, V114, meets primary immunogenicity and safety endpoints

Merck stated that the company’s investigational 15-valent pneumococcal conjugate vaccine, V114, met its primary immunogenicity and safety endpoints in two trials of phase 3 pediatric clinical

22-05-2021

AstraZeneca Covid-19 vaccine, Vaxzevria: Japanese Ministry of Health, Labour, and Welfare (MHLW) grants special approval for emergency use

AstraZeneca’s, Vaxzevria (ChAdOx1-S [Recombinant]), formerly AZD1222, a Covid-19 vaccine, has obtained special approval for emergency use for active immunization of individuals aged 18 years

22-05-2021

Takeda announces MHLW of Japan grants special EUA to Moderna’s mRNA Covid-19 vaccine

Takeda Pharmaceutical announced that MHLW (Ministry of Health, Labour and Welfare) granted special approval for the emergency use of Moderna’s mRNA Covid-19 vaccine under article 14-3 of the

21-05-2021

Takeda declared positive primary analysis from phase 2 OPTIC trial of Iclusig for treating chronic-phase chronic myeloid leukemia

Takeda Pharmaceutical Company announced positive results from primary analysis data from the phase 2 optimizing ponatinib treatment in CML (OPTIC) trial in patients with chronic-phase chronic myelo

21-05-2021

CE Mark approval for OrbusNeich Medical’s TricValve Transcatheter Bicaval Valves System

The TricValve Transcatheter Bicaval Valves System, from the joint partnership of OrbusNeich Medical Company Ltd and P&F Products & Features (OrbusNeich P&F), received CE mark approval.&

21-05-2021

Philips launches the latest Spectral Computed Tomography 7500 system

Royal Philips launched a spectral detector-based Spectral Computed Tomography (CT) 7500, the latest solution for precision diagnosis. 

This new system intelligently delivers high-quali

21-05-2021

BD launches an IVD immunoassay application to assist in patient management decisions in Covid-19

Becton, Dickinson and Company launched its BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with an expanded clinical application in India. 

It aims to identify Covid-19 patien

21-05-2021

Sorrento declared positive results from the phase 1b proof-of-concept study of Enbrel administered by Sofusa Lymphatic Delivery System to treat rheumatoid arthritis

Sorrento Therapeutics announced that the first patient had been treated in a phase 1b proof-of-concept, open-label study to assess the safety, tolerability, and pilot efficacy of Enbrel once weekly

21-05-2021

Chugai's FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for Lynparza to treat BRCA- mCRPC: Japanese approval

Chugai pharmaceutical obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for FoundationOne Liquid CDx Cancer Genomic Profile to be used as a companion diagnostic for the PARP

21-05-2021

COVID-19 antibody detection kit development: DRDO

A laboratory of Defence Research and Development Organisation (DRDO)-Defense Institute of Physiology and Allied Sciences (DIPAS), has developed an antibody detection-based kit, 'DIPCOVAN,' the DIPA

21-05-2021

Medtronic HeartWare system hit with several Class I recalls, device reports since 2012 PMA

A slew of recalls has hit Medtronic's HeartWare HVAD pump system recently. Since it's been on the market, the rate of device malfunction reports documented in an FDA database outpaces competing pro

21-05-2021

A new electrochemical device to identify SARS‑CoV‑2 Spike Protein in a second

Researchers at the University of Florida and the National Chiao Tung University in Taiwan have developed a microfluidic device to detect the SARS‑CoV‑2 spike protein in saliva samples within on

21-05-2021

Intersect ENT's PROPEL Contour sinus implant: receives CE mark

Intersect ENT's PROPEL Contour (mometasone furoate) sinus implant obtained a CE mark promoting its supply and marketing within the European Union.

The implant is outlined to preserve patenc

20-05-2021

Mylabs' COVISELF, home testing kit for COVID-19, gets ICMR approval

The ICMR has approved Pune-based Mylabs' new self-use rapid home-test kit for Covid-19. The new kit can generate results in just 15 minutes.

Named 'COVISELF,' the country's first Covid-19 h

19-05-2021

Medicago and GSK declare positive interim phase 2 trial results for adjuvanted Covid-19 vaccine candidate

Positive results of the interim phase 2 clinical trial safety were declared along with immunogenicity data for Medicago’s plant-derived Covid-19 vaccine candidate. The vaccine is being tested

19-05-2021

Google launches a novel AI tool to detect dermatological conditions

Google introduced an AI-powered dermatology assist tool that uses a phone's camera to detect skin, hair, and nail conditions. 

The internet-based application requires three images of t

18-05-2021

CPC and Fortis Healthcare launch a mental health initiative supporting the elderly during the 2nd Covid wave

Columbia Pacific Communities (CPC) and Fortis Healthcare have launched #ReachOut, a mental wellness initiative. CPC is India’s largest senior living community operator, while Fortis Healthcar

18-05-2021

1mg collaborates with HSSC and Seekify to increase the vaccinator base and scale up Covid-19 vaccination

India’s leading consumer health platform, 1mg, entered a partnership with Seekify and Healthcare Sector Skill Council (HSSC) to impart skills training to healthcare professionals (medical stu

18-05-2021

Orthofix launches a new Ultrasonic arthroplasty revision system in Europe and U.S.

Orthofix Medical launched OSCAR PRO Ultrasonic Arthroplasty Revision System in the U.S. and European market.

OSCAR PRO is an ultrasonic surgical system used to amend

18-05-2021

Abbott receives CE marking for Navitor (TAVI system) to treat aortic stenosis

Abbott got CE Mark for its new-age TAVI (transcatheter aortic valve implantation) system, Navitor, to treat severe aortic stenosis. The latest minimally invasive device can mitigate the high or ext

18-05-2021

Covid-19 vaccine candidate from Sanofi and GSK demonstrates strong immune responses across all adult age groups in phase 2 trial

The adjuvanted recombinant Covid-19 vaccine candidate from Sanofi and GSK achieved potent rates of neutralizing antibody responses, coherent with those measured in people post recovery from Covid-1

18-05-2021

Janssen announced positive data from phase 3 VOYAGER PAD study of Xarelto in combo with aspirin to treat patients with PAD after lower-extremity revascularization at ACC.21

The Janssen Pharmaceutical Companies of Johnson & Johnson's phase 3 VOYAGER PAD study revealed that Xarelto (rivaroxaban) (2.5 mg twice a day) in combination with aspirin (100 mg once daily) pe

17-05-2021

ACON's Flowflex test receives CE certification for self-testing

ACON's Flowflex SARS-CoV-2 Antigen Rapid Test received CE mark approval for self-testing. The CE certificate issued by TUV SUD (CE0123) is valid from 14th May 2021 to 26th May 2024. 

A

17-05-2021

CareNiva to improve the level of patient care with its new AI-driven telehealth platform

Telehealth Company, CareNiva, introduced an artificial intelligence (AI)-driven Telehealth platform to deliver a global healthcare solution for providers. The physician can easily and seamlessly pr

17-05-2021

AI-driven Blood Glucose Prediction Analysis Engine receives CE Mark approval

One Drop secured CE Mark (Conformité Européenne) for its AI-based Blood Glucose Prediction Analysis Engine. The new device can accurately forecast glucose levels up to eight hours in

17-05-2021

Biogen declared positive results from phase 2/3 XIRIUS study of gene therapy, cotoretigene toliparvovec to treat XLR.

Biogen Inc. declared positive results of cotoretigene toliparvovec (BIIB112), a gene therapy investigated as a one-time therapy in patients with X-linked retinitis pigmentosa (XLRP) from the phase

15-05-2021

ReGenTree declares results of additional analysis of phase 3 clinical trial ARISE-3, using RGN-259 for treatment of dry eye syndrome

ReGenTree LLC posted results of additional analysis of phase 3 clinical trial ARISE-3, using RGN-259 to treat dry eye syndrome. The company further declared the consolidated data from all three pha

15-05-2021

Philips brings an integrated Interventional Hemodynamic System with Patient Monitor IntelliVue X3 to enhance workflow and patient focus throughout image-guided procedures.

Royal Philips introduced an integrated system comprising its Interventional Hemodynamic System and market-leading portable Patient Monitor IntelliVue X3. The integration provides advanced hemodynam

14-05-2021

Electrical shorts cause recall of Abbott's Assurity, Endurity pacemakers

Abbott plans to recall 61,973 Assurity and Endurity pacemakers from the U.S. due to electrical shorts resulting in problems like loss of telemetry, loss of pacing, and reduced battery life. FDA sta

14-05-2021

Magnets in certain cell phones and smartwatches may cause pacemakers, other implanted devices to malfunction: FDA

FDA raised a public warning for patients using pacemakers and other implanted medical devices. The agency warned that high-strength magnets in some cell phones and smartwatches could alter these de

14-05-2021

PDP-716 giving positive top-line results from phase 3 trial in open-angle glaucoma treatment: SPARC

SPARC, Sun Pharma Advanced Research Company Ltd., announced positive top-line results from its phase 3 trial (CLR_16_33) of PDP-716 ophthalmic suspension, an investigational drug for treating ocula

14-05-2021

Amgen, AstraZeneca report positive outcomes from NAVIGATOR phase 3 trial of tezepelumab in severe asthma

Amgen and AstraZeneca reported detailed results for tezepelumab from the pivotal NAVIGATOR phase 3 trial demonstrating superiority across all primary and key secondary endpoints in a broad populati

14-05-2021

Merck: Phase 3 KEYNOTE-522 trial attains dual primary endpoint of EFS in high-risk early-stage TNBC patients

Merck (MSD outside the U.S.A. and Canada) announced positive results from the pivotal neoadjuvant/adjuvant phase 3 KEYNOTE-522 trial investigating Keytruda. 

Keytruda is Merck’s

14-05-2021

The Linea Covid-19 Assay Kit from Applied DNA Sciences Inc. gets EUA from USFDA

The USFDA (US Food and Drug Administration) granted a re-issued EUA (Emergency Use Authorization) to Linea Covid-19 Assay Kit from Applied DNA Sciences Inc. The Assay Kit’s use now includes a

12-05-2021

Nasopharynx 3D printed swabs may help streamline COVID-19 tests

A new 3D printed COVID-19 testing swab is now being manufactured in Scotland. It can collect adequate viral material from the back of the nose - without requiring a throat swab. 

The n

07-05-2021

Glooko collaborates with Eli Lilly for connected insulin pens

Eli Lilly entered a collaboration with remote patient monitoring and data management solutions provider, Glooko for its connected insulin pen solutions.

The partnership aims for better

05-05-2021

EMA evaluates Comirnaty use in young individuals aged 12 years and above

European Medicines Agency has initiated the assessment to extend COVID-19 vaccine Comirnaty in young individuals aged 12-15.

The Human Medicine Committee at EMA will conduct accelerated dat

28-04-2021

COVID-19 guidelines for Unani and Ayurveda practitioners: Ayush

Ayush Ministry has released revised guidelines for COVID-19 patients under home isolation. This is specifically for Unani and Ayurveda practitioners to provide preventive measures for self-care.

27-04-2021

Neurolutions' Device receives USFDA approval

USFDA has authorized the use of Neurolutions' device in stroke patients. It can help in regaining movement in the hand, wrist, and arm through brain-computer interface.

It is a non-invasive

27-04-2021

Wearables are not helpful for clinicians

Forrester Research's report on wearables in the healthcare sector suggested these devices have numerous shortcomings. Interviews from more than 40 physicians and patients were taken before the repo

27-04-2021

ROCHE's VENTANA MMR RxDx Panel receives USFDA approval

The USFDA granted approval to Roche's VENTANA MMR RxDx Panel. It will act as a companion diagnostic (CDx) for the identification of advanced or recurrent endometrial cancer patients.

It is

23-04-2021

Medtronic receives FDA nod for its embolization device with shield technology

The (USFDA) United States Food and Drug Administration approved Medtronic’s Pipeline Flex Embolization Device with Shield Technology. The Shield Technology introduces a surface-modified impla

22-04-2021

Implantable Pump Delivers Chemotherapy to Brain Tumors

An electrical pump has been developed to deliver a precise amount of therapeutic drug into the brain. It can be implanted into brain tumor resection sites for an extended period for drug delivery.<

22-04-2021

Wireless sensor for oxygen level monitoring

Researchers at Berkeley's University of California, designed an ultrasound-powered implantable sensor to monitor oxygen levels and transmit the information into an external device.

An on-bo

22-04-2021

AMS receives a CE mark for Seal-G MIST, the laparoscopic GI sealant device

The surgical and advanced wound care specialist company, Advanced Medical Solutions (AMS) Group, received CE mark approval for its laparoscopic gastrointestinal (“GI”) sealant device, S

20-04-2021

Alternative to daily insulin shots

Once-per-week injectable insulin therapy is safe and effective in patients with type 2

19-04-2021

COVID-19 vaccination app in Andhra Pradesh

A user friendly COVID-19 vaccination app has been developed in Andhra Pradesh.

The app will monitor online and capture the information regarding an individual's vaccination across the

19-04-2021

Treatment of drug susceptible tuberculosis: WHO updates

Drug susceptible Tuberculosis (TB) is affecting around 7 million individuals annually. The current treatment includes the use of four first-line medications for 6 months. It is now considered as a

13-04-2021

Thermo Fisher Scientific's new automated system for COVID-19 tests receives FDA's EUA

The U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit.

The

10-04-2021

Positive results of Opdivo plus chemotherapy &Opdivo plus Yervoy to treat unresectable advanced or metastatic ESCC from phase 3 CheckMate -648 trial: Bristol

Bristol Myers Squibb declared positive results from the phase 3 CheckMate -648 trial analyzing treatment with Opdivo (nivolumab) + chemotherapy or Opdivo + Yervoy (ipilimumab) in unresect

10-04-2021

Covid-19 associated with neurological disorders: Neurological experts April 10, 2021

Neurological experts have disclosed that Covid-19 is associated with neurological disorders in several ways. Experts say that common neurological disorders associated with Covid-19 are encepha

10-04-2021

Philips, Ibex Medical Analytics sign collaboration to jointly promote AI-powered digital pathology

Royal Philips, a global leader in health technology, and

Ibex Medical Analytics, a leader in artificial intelligence (AI) based cancer diagnostics, announced a strategic collaboration for p

10-04-2021

Phase 2 trial of Brukinsa in Covid-19 patients with respiratory symptoms fails to meet co-primary endpoints: BeiGene

BeiGene declared that the phase 2 trial evaluating Brukinsa (zanubrutinib) in Covid-19 patients hospitalized with respiratory symptoms, with the need for supplemental oxygen without mechanical vent

09-04-2021

6 Medtronic HeartWare products recalled because of death reports.

FDA has classified another set of products recalled related to Medtronic’s HeartWare HVAD ventricular assist device as a Class I event after receiving reports of deaths associated with the is

09-04-2021

WHO rejects SII's proposal regarding Covishield's shelf life extension: Report

The WHO has rejected the Serum Institute of India's proposal seeking extension of the shelf life of Oxford-AstraZeneca Covid-19 vaccine, Covishield, from six to nine months, indicating insufficient

09-04-2021

TriClip device receives CE Mark approval: Abbott

Abbott announced it had received CE Mark for its next-generation TriClipTranscatheter Tricuspid Valve Repair System to treat TR (tricuspid regurgitation). The system is known as TriClip G4, is a no

09-04-2021

Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device gets US FDA approval

Bausch + Lomb announced that the US Food and Drug Administration (FDA) had approved ClearVisc dispersive ophthalmic viscosurgical device (OVD) for ophthalmic surgery use.

OVDs help in intra

07-04-2021

Dosing in AstraZeneca Covid-19 Vaccine Trial in Children, Teenagers paused: Oxford

The University of Oxford announced pausing dosing of the Covid-19 vaccine, co-developed with AstraZeneca PLC in a small U.K. study in children and teenagers.

This pediatric trial started in

07-04-2021

Suit alleging Medtronic over spine fusion can proceed, appeals court says: misled FDA

A whistleblower lawsuit accusing Medtronic of fraudulently obtaining FDA clearance for several spinal fusion devices can proceed, the U.S. 9th Circuit Court of Appeals has ruled. The plaintiffs &md

05-04-2021

Patient deaths tied to reusable urological endoscopes: FDA warns

The FDA is probing more than 450 reports of patient infection and contamination associated with reprocessed urological endoscopes during the past four years, including three deaths outside the U.S.

13-03-2021

RNA/DNA Shield Collection Tube for Covid-19 testing gets 510(k) clearance from US FDA: Zymo Research

 

Zymo Research declares the US Food and Drug Administration (FDA) clearance of its RNA/DNA Shield Collection Tube as a Class II medical device. The FDA’s 510(k) clearance enable

13-03-2021

Novavax reports 96.4% efficacy on the original COVID-19 virus.

 

Novavax, developing a recombinant vaccine for COVID-19, declared a final efficacy of 96.4% against the original SARS-CoV-2 strain in a pivotal Phase 3 trial in the United Kingdom (U.

13-03-2021

AstraZeneca vaccine safe as injection faces new setbacks: WHO

 

WHO stressed that no causal link had been established between the AstraZeneca vaccine and clotting, as confirmed by the vaccines advisory committee. There was no rationale to stop us

12-03-2021

Emergency Use Listing granted to Johnson & Johnson Single-Shot COVID-19 Vaccine: WHO

 

Johnson & Johnson (NYSE: JNJ) recently declared that the World Health Organization (WHO) had issued Emergency Use Listing (EUL) for its single-shot COVID-19 vaccine, produced by

12-03-2021

False-positive results may occur with the Roche test designed to detect COVID-19 and influenza A/B: FDA alert

 

The FDA alerted about false-positive results associated with the Roche Cobas SARS-CoV-2 (the virus that causes COVID-19) and influenza A/B nucleic acid test may be related to tw

11-03-2021

Launch of qRT-PCR in vitro diagnostic kit to detect SARS-CoV-2 RNA: Agilent

Agilent Technologies announced the launch of a real-time reverse transcription (qRT) PCR-based diagnostic kit to detect SARS-CoV-2 RNA. The CE-IVD mark follows the European Union in Vitro Diagnosti

11-03-2021

ViiV Healthcare announces positive data from phase IIa proof-of-concept study of GSK3640254 to treat HIV

ViiV Healthcare, the global specialist HIV company (largely-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders), presented positive data of the investigational maturation inhibitor

11-03-2021

Philips and openDoctor collaborate to deliver unprecedented digital front door experience in radiology.

Royal Philips and US-based openDoctor declared a partnership to offer an integrated radiology patient engagement platform that advantages openDoctor's real-time online appointment scheduling servic

11-03-2021

Rigenerand collaborates with Lacopa to distribute VITVO 3D cell culture technology

 

Rigenerand SRL, the biotech company, inks the distribution agreement with Lacopa LLC enabling Lacopa to distribute Rigenerand’s VITVO 3D cell culture technology throughout the

10-03-2021

Canakinumab in combo with docetaxel in Phase III CANOPY-2 study to treat locally advanced or metastatic NSCLC fails to meet primary endpoints: Novartis.

 

Novartis declared that Canakinumab (ACZ885), in combination with the chemotherapy agent docetaxel, did not meet its primary endpoint of overall survival (OS) in the phase III CANOPY-

10-03-2021

Aid to 250 underprivileged patients under Free Glaucoma Therapy for Life campaign: Entod Pharma

 

Entod Pharmaceuticals will offer financial support to 250 under-privileged glaucoma patients to ensure they have lifetime access to critical glaucoma medicines. The campaign #FreeGla

10-03-2021

Launch of remote neuromodulation patient-care technology, NeuroSphere Virtual Clinic in US: Abbott

Abbott launched the NeuroSphere Virtual Clinic in the US, allowing patients to ensure proper settings and functionality, communicate with physicians, and receive new treatment settings remotely as

10-03-2021

Scaling up technology & mobile app to train healthcare professionals involved in vaccination: Digital Jalebi

Digital Jalebi is considering scaling up the technology and a mobile-based app that trains healthcare professionals to use augmented reality (AR). The app aims to address the shortage of healthcare

10-03-2021

Positive results of Islatravir subdermal implant to prevent of HIV-1 Infection from phase 1 study: Merck

 

Merck declared positive results from a phase 1 study of investigational sub

10-03-2021

COVID-19 pandemic can affect mother-child through immune pathways: Study

 

The newly released study by associate professor of psychology at the University of Houston, published in Child Psychiatry & Human Development, showed strong evidence to suggest t

10-03-2021

App-based treatment for urinary incontinence- as effective as in-person treatment

 

According to new research from the Netherlands, a mobile app called URinControl was as effective as usual, in-person treatment of urinary incontinence in primary care for women.

09-03-2021

Warning against Fraudsters Offering COVID-19 Vaccines: European Anti-Fraud Office

The European Anti-Fraud Office (Office européen de lutteantifraude - OLAF) has warned governments from dubious offers to provide them with COVID-19 vaccines. These offers are largely fake.

08-03-2021

EUA to Cue Covid-19 Test for over the counter (OTC) and home use: US FDA

The US FDA granted an EUA (emergency use authorization) for the Cue Covid-19 Test for home and OTC use. It is a molecular nucleic acid amplification test (NAAT) intended to detect genetic material

08-03-2021

FSDA, UP blocks Ipca Lab from supplying drugs to hospitals due to the absence of state DC's approval

The FSDA (Food Safety and Drug Administration), Uttar Pradesh, has estopped Ipca Laboratories, Lucknow, from supplying pharmaceutical products to hospitals and medical practitioners without permiss

08-03-2021

New mobile app: diagnoses glaucoma

Scientists from City, University London, supported by Allergan Pharmaceuticals and Glaucoma UK, have launched the latest version of an app for newly diagnosed glaucoma patients.

The launch

08-03-2021

Abbott's Alinity m Resp-4-Plex molecular assay gets US FDA EUA

Abbott announced the US FDA EUA (Emergency Use Authorization) for Alinity m Resp-4-Plex molecular assay to detect and differentiate SARS-CoV-2, respiratory syncytial virus (RSV), influenza A, and i

06-03-2021

Unapproved thermal imaging systems for sale: US FDA alerts consumers, health care providers & users

 

The US Food and Drug Administration (FDA) warned consumers, and health care providers, of thermal imaging systems intended to measure human body temperature—also known as telet

06-03-2021

Eli Lilly's tirzepatide showed superior A1C and body weight reductions across all three doses compared to injectable semaglutide in type 2 diabetic adults.

 

Eli Lilly and Company's 40-week SURPASS-2 clinical trial of Tirzepatide showed body weight reductions and superior A1C from baseline across all three doses compared to injectable sem

06-03-2021

Japanese health ministry’s approval to import and distribute Moderna’s Covid-19 vaccine candidate: Takeda

 

Moderna, a biotechnology company, declared that Takeda

Pharmaceutical submitted a New Drug Application (NDA) to MHLW (the Government of Japan’s Ministry of Health, Labo

05-03-2021

T-Detect COVID Test gets Emergency use authorization from FDA

The U.S. FDA granted an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is an NGS (next-generation sequencing-based) tes

05-03-2021

Launch of screening machine, Kribado for healthcare practitioners in diagnosing, treating patients at pre-admission level: Indigital Technologies

Indigital Technologies has launched a hand-held screening machine, Kribado that will help healthcare practitioners diagnose and treat patients at the pre-admission level.

Kribado is th

05-03-2021

Luminex's expanded NxTAG Respiratory Panel Test Including SARS-CoV-2: US FDA Emergency Use Authorization and CE Mark

Luminex Corporation had received Emergency Use Authorization (EUA) for a new expanded version of its NxTAG Respiratory Pathogen Panel (RPP), including the SARS-CoV-2 virus for high-throug

04-03-2021

Launches first portable x-ray device FDR Xair XD2000: Fujifilm India

Fujifilm India Private Limited announced Fujifilm’s first portable X-ray device FDR Xair XD2000 that can easily be used with limited space and resources, providing quick and easy access to di

04-03-2021

Launch of QIAcube Connect MDx platform: QIAGEN

QIAGEN declared the global launch of the QIAcube Connect MDx, a platform for automated sample processing available to molecular diagnostic laboratories in the US and Canada, the European Union, and

04-03-2021

Launch of Covid-19 testing and vaccine management suite: TCS

Tata Consultancy Services (TCS) declared the launch of the Covid-19 vaccine management and testing suite.

This suite of modular, easy-to-deploy solutions simplifies every stage of the

04-03-2021

Announcement of phase 3 results of Covaxin: Bharat Biotech

 

Bharat Biotech, a global leader in vaccine innovation, developing vaccines for infectious diseases, announced the first interim analysis of its BBV152 Covaxin.

The Covid-19 v

03-03-2021

World Report on Hearing depicts 1 in 4 people projected to have hearing problems by 2050: WHO

 

Approximately 2.5 billion people worldwide - or 1 in 4 people - will live with some minor hearing loss by 2050 and warns the World Health Organization’s (WHO) first World Repor

03-03-2021

Launch of multilingual pediatric vaccine awareness campaign on Public App: GSK Pharma

 

GlaxoSmithKline Pharma launched a massive public interest campaign called "Health ka Passport" on Public App across all major Indian languages. The ad campaign seeks to educate child

03-03-2021

Positive results from Inovio's REVEAL 1 trial of VGX-3100 to treat high-grade precancerous cervical dysplasia caused by HPV-16/18

 

Inovio declared that positive results from REVEAL 1 trial. This trial is one

03-03-2021

Launch of contactless remote patient monitoring solution for hospitals: Dozee

Dozee declared the launch of Dozee Pro, a Contactless Vitals Monitor for hospitals. The device features an AI-powered triaging system that converts any bed into a step-down ICU in under 2 minutes.

03-03-2021

FDA cites danger to humans

 

Bravo Packing Inc. of Carneys Point, NJ, recalls all of its raw frozen pet food — ground beef and “Performance Dog” — after tests showed contamination with Sa

02-03-2021

US FDA Emergency Use Authorization to Eurofins EmpowerDX Covid-19 Home Collection Kit

 

Eurofins’s Clinical Enterprise announced the grant of US FDA Emergency Use Authorization (EUA) for its EmpowerDX Covid-19 Home Collection Kit, a direct-to-consumer (DTC) versio

02-03-2021

US FDA Emergency Use Authorization to Eurofins EmpowerDX Covid-19 Home Collection Kit

 

Eurofins’s Clinical Enterprise announced the grant of US FDA Emergency Use Authorization (EUA) for its EmpowerDX Covid-19 Home Collection Kit, a direct-to-consumer (DTC) versio

02-03-2021

Moderna vaccine decreases viral spread by at least 60 percent: Study

 

An interesting new study by researchers at Harvard T.H. Chan School of Public Health in the U.S. suggests that the currently used Moderna vaccine reduces viral shedding by about 60%.

01-03-2021

Single-shot Covid-19 vaccine obtains US CDC panel recommendation: Johnson & Johnson

 

Johnson & Johnson declared that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first&

01-03-2021

Results announced from phase 2 OSCAR study evaluating otilimab for treating hospitalized Covid patients: GSK

GlaxoSmithKline plc (GSK) declared results from the proof

of concept OSCAR (Otilimab in Severe Covid-19 Related Disease) phase 2 study

with otilimab.

The primary endpoint wa

01-03-2021

Amgen and AstraZeneca announce successful phase 3 results of tezepelumab; to widen treatment options for severe asthma

 

AstraZeneca Plc and Amgen Inc jointly announced the phase 3 clinical trial results of the biologic tezepelumab in severe and uncontrolled asthma patients. It demonstrated a clinicall

01-03-2021

Launch of FDR Nano, digital radiology system: Fujifilm India

 

Fujifilm India Private Limited declared the launch of its mobile digital radiology system – FDR Nano. This new digital radiology technology with high-resolution imaging with lo

01-03-2021

Launch of FDR Nano, digital radiology system: Fujifilm India

 

Fujifilm India Private Limited declared the launch of its mobile digital radiology system – FDR Nano. This new digital radiology technology with high-resolution imaging with lo

27-02-2021

Launch of campaign to raise awareness on depression and other mental health issues: United We Care

 

United We Care, a web and app-based platform for emotional well-being, recently launched a campaign to increase awareness on depression and other mental health issues.

It ask

27-02-2021

Reduced transmission after one dose of Pfizer's Covid-19 vaccine: UK study

 

Pfizer and BioNtech's Covid-19 vaccine's single-dose reduces the number of asymptomatic infections. It could significantly reduce the risk of transmission of the virus depicted from

27-02-2021

Qiagen and INOVIO expand partnership into developing liquid biopsy diagnosis on NGS technology to treat cervical dysplasia

 

Qiagen, a Netherlands-based holding company, and INOVIO Pharmaceuticals, a biotechnology company, declared an extension of their collaboration with a new master partnering agreement

27-02-2021

US FDA approves nasopharyngeal specimen collection swabs RT-PCR test kit: MJ Biotech's

 

MJ Biotech declared US Food and Drug Administration (FDA) approval of Sterile and individually wrapped nasopharyngeal (NP) specimen collection swabs for the RT-PCR Covid test. This C

26-02-2021

CityHealth brings a novel home-based Covid-19 testing kit.

CityHealth Urgent Care, a healthcare clinic in the US, has come up with a new home-based test kit for Covid-19 patients.

The In-Home COVID-19 Test Kit contains a how-to guide, a sterile swa

25-02-2021

BioIQ collaborates with Assurance Scientific for in-home Covid-19 test kits.

BioIQ and Assurance Scientific Laboratories have partnered to bring over-the-counter (OTC) RT-PCR Covid-19 testing kits in the market.

They have received the US Food and Drug Administration

25-02-2021

Medtronic issued a global recall of unused Valiant Navion thoracic stent graft systems

 

A safety issue has induced Medtronic to issue a global recall of unused Valiant Navion thoracic stent graft systems during a worldwide clinical trial. For the sake of patient safety,

24-02-2021

FDA stops Hand Sanitizers with very low Alcohol Content at the U.S. Border

 

The U.S. Food and Drug Administration is closely observing the content of hand sanitizer products imported into the United States. Of late, a product calle

29-01-2021

Launch of #YesICan campaign to create awareness on leprosy: Sasakawa-India Leprosy Foundation

 

Sasakawa-India Leprosy Foundation (S-ILF) launched the #YesICan campaign to generate awareness amongst the folks on the eve of Anti-leprosy Day. The campaign intended to create aware

28-01-2021

AstraZeneca vaccine shouldn't be given to over-65s, citing lack of data

 

Germany's vaccine commission said the AstraZeneca coronavirus should not be given to people aged over 65 years, amid a sour dispute between the European Union and the drugmaker over

28-01-2021

Positive results of VIR-3434 in patients with chronic hepatitis B virus from phase 1 trial: Vir Biotechnology

 

Vir Biotechnology declared initial topline data from its ongoing trial of VIR-3434 with chronic hepatitis B virus (HBV) infected patients. 

VIR-3434 is an HBV-neutralizi

28-01-2021

Positive results from once-daily relugolix combo therapy in women with endometriosis: Myovant and Pfizer phase 3 SPIRIT extension study

 

Myovant Sciences and Pfizer declared that relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg (the investigational once-daily relugolix combination therapy) in end

28-01-2021

Symbicort Turbuhaler receives China NMPA approval as an anti-inflammatory reliever in mild asthma: AstraZeneca

 

AstraZeneca declared that its Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) is approved in China as an anti-inflammatory reliever to be used as needed in response to sympto

28-01-2021

Panbio Covid-19 Ag rapid test device granted CE Mark for asymptomatic screening and self-administered sample collection with nasal swab: Abbott

 

Abbott declared that it had rec

27-01-2021

Renewed partnership to deliver hematology testing solutions: Roche and Sysmex

 

Roche declared that it entered into a Global Business Partnership Agreement (GBP) with Sysmex. Under this, the parties renewed their commitment to the extended-standing distribution,

27-01-2021

ADLINK Technology introduces a new range of surgical monitors

 

ADLINK Technology launched the ASM (ADLINK Surgical Monitor) series of surgical monitors developed for integration with microscopic, fluoroscopic, endoscopic, multi-mo

27-01-2021

Calquence’s ELEVATE-RR phase III trial meets primary endpoint to treat CLL: AstraZeneca

 

AstraZeneca declared positive high-level results from the ELEVATE-RR phase III trial of Calquence (acalabrutinib). The study met the primary endpoint showing non-inferior PFS (progre

27-01-2021

Faricimab’s Phase III TENAYA & LUCERNE studies to treat nAMD (neovascular or wet age-related macular degeneration) meet primary endpoint: Roche

 

Roche declared positive results from TENAYA and LUCERNE (two identically designed global phase III studies), analyzing its investigational bispecific antibody, faricimab, in people w

26-01-2021

Launch of "Game-changing," 24/7 automated Blood Pressure monitoring system

 

Aktiia announced a 24/7 automated blood pressure monitoring system in the UK after receiving CE Mark as a Class IIa medical device. It can record blood pressure data throughout the d

26-01-2021

Positive results from Carragelose lozenges against respiratory viruses of SARS-CoV-2: Marinomed

 

Marinomed Biotech AG declared positive results from its clinical study on the antiviral efficacy of Carragelose-containing lozenges (10 mg iota-carrageenan) in 31 healthy subjects. R

26-01-2021

Positive results from part 1 of pivotal FIREFISH study Evrysdi in infants with Type 1 spinal muscular atrophy: Roche

 

Roche declared that the New England Journal of Medicine had published data from the dose-finding Part 1 of the pivotal FIREFISH study of Evrysdi (risdiplam) in infants with symptomat

26-01-2021

Chondro3 receives US FDA breakthrough device designation: Locate Bio

Locate Bio declared that the US Food and Drug Administration granted Breakthrough Device designation to Chondro3 - a biomimetic graft for osteochondral lesions. Chondro3 is currently in development

25-01-2021

Scientists demand stern control measures to mitigate the spread of new COVID-19 variants

 

A group of scientists having expertise in evolution, virology, infectious disease, and genomics from the University of East Anglia (UEA), Earlham Institute, and University of Minneso

25-01-2021

Experts conduct a review of deaths reported in Europe after BNT162b2 vaccination

 

The virtual meeting of the GACVS COVID-19 Vaccine Safety subcommittee held on January 19, 2021, to evaluate the information and data available on deaths reported in frail, elderly in

25-01-2021

Opening of Jan Aushadhi outlets in all PHCs: AP govt plans

 

The Andhra Pradesh (AP) government is aggressively working to open the PMBJK (Pradhan Mantri Bhartiya Janaushadhi Kendras) outlets or Jan Aushadhi Stores in all the public health cen

25-01-2021

Methamphetamine overdose deaths rise acutely among American Indians & Alaska Natives: Finding from NIH-supported study

 

Methamphetamine overdose deaths surged in eight years in the United States, according to a study that will be published in JAMA Psychiatry. The analysis revealed a rapid increase acr

25-01-2021

Launch of Assay to detect a patient's COVID-19 antibody levels

 

Beckman Coulter, a clinical diagnostics firm, launched its Access SARS-CoV-2 IgG II assay in the CE mark accepting countries. The new assay quantitatively measures a patient's antibo

24-01-2021

Second-generation "double antibody" offers protection from SARS-CoV-2 and its tested variants

 

The Institute for Research in Biomedicine (Switzerland), affiliated to the Università Della Svizzera Italiana (USI), has come up with a second-generation 'double-antibody' tha

23-01-2021

Elecsys Anti-SARS-CoV-2 S test against SARS-CoV-2: Roche Diagnostics

 

Roche Diagnostics India declared the launch of its antibody test SARS-CoV-2 test - Elecsys Anti-SARS-CoV-2 S.

The test is CE IVD approved and has received ICMR and CDSCO appr

23-01-2021

OraSure’sOrageneDx saliva collection kit included in industry’s first US FDA authorization for whole-exome sequencing platform

 

OraSure Technologies declared that its OrageneDx (OGD-610) saliva collection device was incorporated as a component in the De Novo authorization granted by the US FDA for a whole-exo

23-01-2021

Bamlanivimab's Phase 3 BLAZE-2 trial reduces the risk of contracting symptomatic Covid-19 up to 80% for residents: Lilly

 

Eli Lilly and Company declared that bamlanivimab (LY-CoV555) significantly decreased the risk of contracting symptomatic Covid-19 in long-term care facilities staff and residents.

23-01-2021

USFDA new norms for ANDAs to ensure patient safety & data integrity in BE studies, during this pandemic

 

Indian clinical trial sector welcomes US FDA new norms to protect participants in BE studies for ANDAs (abbreviated new drug applications) to ensure patient safety and data integrity

22-01-2021

Boston Scientific's Vercise Genus deep brain stimulation system receives FDA approval

 

The FDA approved Boston Scientific's Vercise Genus deep brain stimulation (DBS) system portfolio for conditional use in a magnetic resonance imaging (MRI) environment. It comprises o

22-01-2021

Association between impaired metabolic health, obesity, and COVID-19 severity

 

The authors from the German Center for Diabetes Research (DZD) spotlight the link between obesity and impaired metabolic health with the COVID-19 severity in a Nature Review

21-01-2021

Lightpoint Medical receives CE mark approval for its Robotic gamma probe for intra-operative cancer detection

 

Medical device company Lightpoint Medical's Robotic gamma probe for intra-operative cancer detection received CE mark approval. The miniaturized surgical tool named SENSEI is designe

21-01-2021

Bharat Biotech issues fact sheet for Covaxin

 

Bharat Biotech has officially released a fact sheet for its Covaxin Covid-19 vaccine, indicating that the vaccine is contraindicated in people who have allergies, fever or bleeding d

20-01-2021

VaxArray Measles & Rubella antigen quantification kit: InDevR

 

InDevR, a life science tools company, announced its VaxArray Measles and Rubella (MR) antigen quantification kit's commercial availability.

The Bill and Melinda Gates Foundat

20-01-2021

MHRA approves CoverScan MD, Imaging service for Long-COVID-19

 

The (MHRA) Medicines & Healthcare products Regulatory Agency of UK approved Perspectum's CoverScan MD, an MRI-based technology to map the effects of COVID-19 on several of the bo

20-01-2021

Positive results of Fotivda in combo with Imfinzi from phase portion of DEDUCTIVE trial to treat patients with advanced or metastatic HCC: AVEO Oncology

 

AVEO Oncology declared the presentation of results of Fotivda (tivozanib), in combination with AstraZeneca’s human monoclonal antibody directed against programmed death-ligand

19-01-2021

Positive phase 1 results of high-dose setanaxib in primary biliary cholangitis patients: Genkyotex

 

A Calliditas Therapeutics AB's (publ) subsidiary, Genkyotex SA, declared positive phase 1 data with a commendatory pharmacokinetic and safety profile of high-dose setanaxib.

18-01-2021

MLC-AL & MLC-KL(medical panel computers): ADLINK Technology

 

ADLINK Technology Inc. has launched the MLC-AL and MLC-KL series of medical panel computers specifically developed for integrated system control and complex medical data management.

18-01-2021

Researchers discover a nutrient that can help in the prevention of bacterial infection

 

Scientists at the National Institutes of Health (NIH), USA, are conducting and supporting basic, clinical, and translational medical research to investigate the causes, treatments, a

18-01-2021

Phase 2 FIGHT trial assessing bemarituzumab in advanced gastric/GEJ cancer meets all three efficacy endpoints: Five Prime Therapeutics

 

Five Prime Therapeutics, Inc., declared clinical results from the global, double-blind placebo-controlled, randomized, phase 2 FIGHT trial analyzing first-in-class targeted therapy b

18-01-2021

SCTIMST enters technology transfer agreement with Biorad Medisys for intracranial flow diverter stent

 

SCTIMST signed technology transfer agreements with the Pune-based Biorad Medisys for two biomedical implants, an intracranial flow diverter stent and an atrial septal defect occ

18-01-2021

ICMR allows Neuberg to conduct COVID-19 tests in Noida, Salem, Vizag, and Kozhikode

 

The Indian Council of Medical Research (ICMR) granted Neuberg Diagnostics approval to conduct Covid-19 tests in Noida, Vizag, Salem, and Kozhikode. Neuberg Diagnostics is the fourth

18-01-2021

MyHealthcare and AliveCor join hands for home-based ECG monitor, KardiaMobile 6L

 

MyHealthcare and AliveCor announced their partnership for their KardiaMobile 6L device that allows patients to read their ECG data at home. The collaboration brings an integrated car

16-01-2021

PerkinElmer's Coronavirus Nucleic Acid Detection Kit: US FDA emergency use authorization

 

PerkinElmer declared that its New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the US FDA to test individuals without symptoms or other reas

16-01-2021

Merck and Philips partnership to develop clinical-grade digital solutions for personalized fertility treatment

 

Royal Philips declared a multi-year partnership with Merck to develop clinical-grade digital solutions for highly customized fertility treatment. These solutions aim to better inform

15-01-2021

Launch of digital health app: Abbott

 

Abbott's neuromodulation portfolio is around Proclaim XR, a version of a St. Jude Medical spinal cord stimulation (SCS) device approved by the FDA in 2015, and the Proclaim DRG Syste

15-01-2021

Market release of SCS systems: Boston Scientific

 

Boston Scientific has enlarged its SCS portfolio with the limited market release of its WaveWriter Alpha SCS (Spinal Cord Stimulator) Systems. The port

13-01-2021

Rehabilitation tech tie-up: maxon and Fourier Intelligence

 

maxon Group and Fourier Intelligence declared about entering into a global strategic partnership to develop rehabilitation technologies.

Technology

11-01-2021

COVID-19 false-negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests: Flagged FDA

 

The FDA alarmed healthcare providers and clinical laboratory staff regarding the U.K. coronavirus variant and other emerging forms of the virus' impact on specific PCR test results.<

06-01-2021

Pfizer-BioNTech vaccine approved for emergency use: Colombia regulator

 

Colombia’s food and drug regulator recently authorized the emergency use of Pfizer Inc and BioNTech SE’s COVID-19 vaccine.

The National Institute of Food and Drug

06-01-2021

Grants 510(k) clearance to Accuray'sClearRT Helical kVCTImaging for Radixact treatment delivery system: US FDA

 

Accuray Incorporated declared about grant of 510(k) clearance from the US Food and Drug Administration (FDA) for its ClearRT Helical kVCTImaging for the Radixact System, the latest T

04-01-2021

Nod to Bharat Biotech & SII vaccine candidates for restricted emergency use in India for management of COVID-19: CDSCO

 

The Central Drugs Standard Control Organisation (CDSCO) has approved Serum Institute of India (SII) and Bharat Biotech vaccines named Covishield and Covaxinfor, respectively, for res

04-01-2021

Positive results with opaganib in patients hospitalized with COVID-19 pneumonia: RedHill Biopharma's phase 2 study

 

RedHill Biopharma Ltd. declared the preliminary positive data with orally-administered opaganib (Yeliva, ABC294640) in patients hospitalized with COVID-19 pneumonia. The US phase 2 s

02-01-2021

Seeks marketing approval for COVI-STIX rapid detection test of SARS-CoV-2 viral antigen: Sorrento Therapeutics San Diego

 

Sorrento Therapeutics declared that its agents in Mexico had submitted a Marketing Authorization Application to Mexico's health regulatory authority for its COVI-STIX rapid diagnosti

02-01-2021

Micro-Tech Endoscopy and Interscope ink partnership to distribute EndoRotor System for interventional gastroenterology

 

Micro-Tech Endoscopy and Interscope Inc signed a partnership agreement to collaborate and distribute the EndoRotor System for interventional gastroenterology. 

It is a s

02-01-2021

Issuance of emergency use validation for Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty: WHO

 

The WHO declared the Comirnaty vaccine for emergency use, resulting in the Pfizer/BioNTech vaccine to be the pioneer to get emergency validation from WHO since the outbreak began a y

29-12-2020

Fitgo launches a range of infrared thermometers with the latest technology

 

Fitgo has come up with a range of infrared thermometers with the latest technology that may be launched worldwide. The new devices have advanced sensor technology that gives results

23-12-2020

Medtronic launches The Tri-Staple EEA™ Circular Stapler In India

 

Medtronic India launched EEA™ Circular Stapler with Tri-Staple™ Technology. It is touted as the first 3-row Circular Stapler with varied height staples causing lesser str

22-12-2020

Phase 3 LACEWING trial of Xospata plus azacitidine fails to meet primary endpoints to treat acute myeloid leukemia: Astellas Pharma.

 

Astellas Pharma declared that a phase 3 trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) AML (acute myel

22-12-2020

Phase 3 YOSEMITE and RHINE trials of faricimab meets primary endpoints to treat diabetic macular edema (DME): Roche

 

Roche declared positive results from two identically designed-YOSEMITE and RHINE, randomized, multicentre, double-masked, global phase III studies, evaluating its investigational bis

22-12-2020

Health Canada approves Micra AV pacemaker from Medtronic

 

Health Canada granted its approval to Medtronic Canada's Micra AV pacemaker with atrioventricular synchrony. The USFDA approved the device in January 2020. 

The leadless

22-12-2020

Rapid Medical’s steerable neurovascular guidewire gets FDA clearance

 

The USFDA granted clearance to Rapid Medical’s Drivewire; the guidewire used to treat vascular diseases.

The Israel-based company aims to help treating doctors control

22-12-2020

The error rate of pulse oximeters reportedly increases in Black patients

 

According to a study shared with the New England Journal of Medicine, pulse oximeters have a higher error rate with Black patients. The study states that the handy devices may give m

22-12-2020

FDA grants EUA to Quidel's instrument-free COVID-19 antigen test

 

Quidel's instrument-free COVID-19 antigen test received FDA's emergency use authorization (EUA). It is a pregnancy test-style product that can deliver results in minutes.

Qui

17-12-2020

Implant meant to fix ACL tears gets FDA De Novo

 

FDA has approved a resorbable implant under the De Novo premarket review pathway that can fill the crack between the torn ends of a person's anterior cruciate ligament (ACL). It is o

17-12-2020

Penumbra recalls catheter device: FDA's request

 

The catheter device, Jet 7 Xtra Flex, of Penumbra is recalled because of the injury risk and even death during removing clots in stroke patients, after FDA advice. The company announ

12-12-2020

Launch of Elecsys SARS-CoV-2 antigen test to detect COVID-19: Roche

 

Roche declared the launch of the high-throughput SARS-CoV-2 antigen test to aid in diagnosing SARS-CoV-2 infections (Severe Acute Respiratory Syndrome Coronavirus 2) with the CE Mark

10-12-2020

Co-WIN mobile app for COVID-19 vaccine delivery

 

The Central government has launched a new digital platform called Co-WIN for COVID-19 vaccine delivery. There will be a new mobile app and will allow people vaccine registration.

10-12-2020

HealthiumMedtech launches Surestitch, a meniscal repair device

 

HealthiumMedtech has come up with the first 'Made in India' meniscal repair device. The device named 'Surestitch' is a part of its arthroscopy range Sironix. The company has applied

09-12-2020

Updated guidance issued on systematic screening of tuberculosis (TB) disease: WHO

 

In a Rapid Communication issued, the World Health Organization (WHO) declared several updates to its prospective guidance on TB disease's systematic screening. The updated guidance w

09-12-2020

Carpediem cardio-renal pediatric dialysis emergency machine: Medtronic, US

 

Medtronic plc declared the commercial launch of the Carpediem cardio-renal pediatric dialysis emergency device. After the US FDA marketing authorization grant earlier this year, the

08-12-2020

CE mark approval to Advaite’s RapCov rapid antibody test for COVID-19

 

Advaite, an innovative biotechnology company, declared that it had obtained CE Mark approval for its rapid IgG antibody test called RapCov, which will help contain the spread of coro

08-12-2020

Launch of QuantiFERON SARS-CoV-2 RUO solution to detect T-cell response: QIAGEN

 

QIAGEN declared the launch of its QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution to detect T-cell responses of the immune system to the COVID-19 causing pathogen in humans,

08-12-2020

Positive results of Yescarta to treat large B-cell lymphoma phase 2 ZUMA-12 study: Kite

 

Kite declared positive results from the interim analysis of ZUMA-12, a multicenter, open-label, single-arm phase 2 study evaluating Yescarta (axicabtageneciloleucel) as first-li

07-12-2020

Omron presents a new wheeze detection device

 

Omron Healthcare has come up with an automatic wheeze detection device, WheezeScan. It is primarily meant for domestic use and detects the presence of a wheeze in young children.&nbs

07-12-2020

Omron presents a new wheeze detection device

 

Omron Healthcare has come up with an automatic wheeze detection device, WheezeScan. It is primarily meant for domestic use and detects the presence of a wheeze in young children.&nbs

07-12-2020

New COVID-19 testing technique developed by CCMB scientists

 

The scientists from CCMB (Centre for Cellular and Molecular Biology), Hyderabad, have designed an innovative and most effective COVID-19 testing technique utilizing dry swabs, which

04-12-2020

MEQU launches a new and improved battery for blood and IV warming devices

 

MEQU, a Danish Medtech company, announced a new battery for M Warmer System, the compact blood and IV fluid warming device. Appropriately brand named Power Pack, the new battery has

04-12-2020

CDSCO approves Three GOQii Wearables as Medical Device.

 

the Central Drugs Standard Control Organization (CDSCO) approved three wearable devices from GOQii for medical device registration.

The devices Smart Vital, Vital 3.0, and Vi

23-11-2020

FDA approval to Baxter's Home Peritoneal Dialysis System

 

Baxter has received FDA approval for Homechoice Claria with the Sharesource Connectivity platform for adult and pediatric populations.

The technology is a home peritoneal dia

23-11-2020

New AI-Powered Test in IVF Patients: Better Predicts Ongoing Pregnancy and Live Birth Rates

 

CooperSurgical’s PGTai 2.0 technology is a machine learning AI, with statistical analysis, omitting human subjectivity from the procedure. The technique works by testing embryo

13-11-2020

Positive results of abrocitinib to treat atopic dermatitis from phase 3 JADE REGIMEN study: Pfizer

 

Pfizer declared positive results from the phase 3 JADE REGIMEN study. This 52-week study analysed abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in

11-11-2020

Positive results from COVID-19 mRNA-based vaccine candidate, BNT162b2's phase 3 study: Pfizer, BioNTech

 

Pfizer and BioNTech declared their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 demonstrated efficacy against COVID-19 in participants without prior proof of SARS-CoV-2

11-11-2020

NAVIGATOR phase III trial of tezepelumab in asthma patients meets primary endpoints: AstraZeneca and Amgen

 

AstraZeneca and Amgen declared positive results from the NAVIGATOR phase III trial of tezepelumab in patients with severe, uncontrolled asthma.

Tezepelumab is a potential fir

10-11-2020

Positive results of interim phase 2 study of AP1189 in Rheumatoid Arthritis: SynAct Pharma

 

SynAct Pharma AB declared positive results of interim phase 2 study in patients with rheumatoid arthritis (RA) with high disease activity to recommend which dos

10-11-2020

Positive results from denileukin diftitox in patients with cutaneous T cell lymphoma at SITC 2020: Dr Reddy’s Labs

 

Dr Reddy’s Laboratories declared preclinical data presentation for its engineered IL-2-diphtheria toxin fusion protein, E7777 (denileukin diftitox), at The Society for Immunoth

10-11-2020

Launch of new brand FitGo: Smart Tech Overseas

 

Smart Tech Overseas declared a new brand launch, FitGo, to nurture a healthy routine of life worldwide with its modern medical innovations.

FitGo's first few products in the

10-11-2020

Launch of New PHST for catheter-based procedures

 

Junkosha launched its latest innovation, cut-to-length and slit Peelable Heat Shrink Tubing (PHST), to enable a range of catheter-based procedures where flexibility is the fundamenta

10-11-2020

Launch of antibody test with 99.9% specificity: Beckman Coulter

 

Beckman Coulter has launched its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in CE mark accepting countries. 

The new antibody test demonstrated 99.9% specificity wit

10-11-2020

Positive results of Nefecon in patients with primary IgA nephropathy from phase 3 NefIgArd trial: Calliditas

 

Calliditas Therapeutics declared positive results of Nefecon from Part A of the global phase 3 clinical trial NefIgArd, in patients with primary IgA nephropathy (IgAN).

The t

07-11-2020

Positive results from SENSCIS-ON trial evaluating nintedanib in SSc-ILD patients: Boehringer Ingelheim

 

Boehringer Ingelheim declared positive interim results from the SENSCIS-ON trial evaluating nintedanib in systemic sclerosis-associated interstitial lung disease (SSc-ILD) patients.<

06-11-2020

Developed affordable high-end ventilators: Nocca Robotics

 

Nocca Robotics, is developing economical high-end ventilators

The company is also working on regulatory aspects to export the Noccarc H210 machines and is on track to deploy

06-11-2020

Affordable high-end ventilators: Nocca Robotics

 

Nocca Robotics is developing economical high-end ventilators.The company is also operating on regulatory aspects for Noccarc H210 machines export and is ready to install 400 high flo

04-11-2020

Inito Fertility Monitor receives USFDA approval

 

Bengaluru-based medical technology startup Inito's Fertility Monitor had received the United States Food and Drug Administration approval, resulting in the product's launch in the US

02-11-2020

Biodegradable Patch to Monitor Glucose


Anna University researchers have developed a biodegradable material, a cellulose derivative-based polymer, for detecting glucose and alcohol levels from swea

02-11-2020

Positive results from GENESIS motixafortide phase 3 trial in stem cell mobilization: BioLineRx

 

BioLineRx Ltd., a biopharmaceutical company, declared positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide in multiple myeloma patie

02-11-2020

Positive data of Ilumya from pooled reSURFACE 5-year phase 3 extension studies: Sun Pharma

 

Sun Pharmaceutical Industries Limited declared that one of its subsidiaries presented positive data for Ilumya (tildrakizumab-asmn) from the combined five-year phase 3, reSURFACE 1 r

01-11-2020

Covid Test Kit Based On RT-LAMP Technology: Agappe Diagnostics

 

Kochi-based medical devices manufacturer, Agappe Diagnostics Ltd, is launching a new Covid-19 test kit on November 10, based on Reverse Transcription Loop-mediated Isothermal Amplifi

31-10-2020

Awareness on women's health & breast cancer: HCG in collaboration with Pinkathon

 

HCG, the cancer care specialist, in collaboration with Pinkathon, hosted The Pink Strong Talks, a live session to create awareness on 'women's health and breast cancer' virtually to

31-10-2020

PerkinElmer New Coronavirus Nucleic Acid Detection Kit granted Emergency use authorization: US FDA

 

PerkinElmer, Inc. declared that the US Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA), which allows sample pooling with PerkinElmer New Coronavirus

31-10-2020

CRISPR-based SARS CoV-2 diagnostic test: Merck collaboration with Mammoth Biosciences

 

Merck declared collaboration with Mammoth Biosciences for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test.

Mamm

30-10-2020

Positive results from phase 2/3 COVID-19 outpatient trial of investigational antibody cocktail, REGN-COV2 : Regeneron Pharma

 

Regeneron Pharmaceuticals Inc declared positive results from an ongoing phase 2/3 COVID-19 outpatient trial analyzing its investigational antibody cocktail, REGN-COV2. The trial resu

30-10-2020

Triboelectricity based India's first face mask-3bO

 

Camellia Clothing, a clothing company based in Bangalore, under an exclusive global license from CeNS, has manufactured and is marketing a 3bO face mask. This is India’s first

29-10-2020

Genbody antigen test kits: ICMR approval

 

Global Diagnostic firm Genbody Inc has received the Indian Council of Medical Research and Drugs Controller General of India's approval for "Genbody Covid-19 AG" antigen test kits to

28-10-2020

Cipla collaborates with KARWA Ltd. to launch Covid-19 antibody detection kits in India

 

Cipla and KARWA Ltd. have collaborated to launch Covid-19 antibody detection kits in India with the brand name ‘ELIFast.’ KARWA ltd. will be responsible for manufacturing

28-10-2020

Companies to set up mandatory PV cells to generate COVID-19 drugs' ADR data: Health ministry

 

In the wake of the ongoing pandemic, the Union health ministry has ordered pharmaceutical companies to set up PV (Pharmacovigilance) cells on war footing after due considerations to

27-10-2020

US FDA's draft norms on PMS quite relevant, Industry claims, as a slew of COVID-19 drugs enter the market

 

Indian pharma industry sees enough pertinence to the recently released draft guidance on postmarketing obligations by the US FDA. 

This is because of the COVID-19 drugs

27-10-2020

Development of powered air-purifying respirators for health workers: SCTIMST


The Sree Chitra Tirunal Institute for Medical Science and Technology (SCTIMST), a Thiruvananthapuram-based Centre of Excellence under the Department of Scien

26-10-2020

USFDA grants emergency use authorization to South Korea’s Celltrion's Covid test

 

US Food & Drug Administration (FDA) has approved Celltrion Inc.’s rapid Covid-19 testing kit, Sampinute, for emergency use authorization (EUA). The company initiated the re

26-10-2020

West Pharma launches Vial2Bag Advanced 20mm Admixture Device after US FDA clearance

 

US Food & Drug Administration (FDA) granted 510(k) clearance to the Vial2Bag Advanced 20mm Admixture Device from West Pharmaceutical Services Inc. The company has announced its l

26-10-2020

Bayer's FoundationOneCDx as companion diagnostic for Vitrakvi to aid in identifying NTRK fusion-positive patients: US FDA approval

 

Bayer's FoundationOneCDx for use as the first companion diagnostic gets US FDA approval for identifying neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients whe

25-10-2020

ICMR formally announces the approval to use Feluda Paper Strip Test for COVID-19

 

The Indian Council of Medical Research (ICMR) issued an advisory related to the use of the Feluda paper strip test, by the laboratories, for diagnosis of SARS-CoV-2. The test based o

24-10-2020

Researchers come up with a new tool to diagnose stroke using a smartphone

 

Scientists have come up with a novel tool to assist physicians and speed up stroke diagnosis in clinical settings. The new tool based on machine learning may help diagnose stroke and

23-10-2020

Positive results from phase 3 BRAAVE 2020 study of Biktarvy to treat HIV in black Americans: Gilead

 

Gilead Sciences declared 48-week data from the BRAAVE 2020 study, a phase 3 clinical trial analysing the efficacy and safety of switching from a standard regimen of two nucleoside re

23-10-2020

Positive results of phase 1 CARBON trial of CTX110 to treat r/r CD19+ B-cell malignancies: CRISPR Therapeutics

 

CRISPR Therapeutics, a biopharmaceutical company, declared positive results from the ongoing phase 1 CARBON trial analyzing the efficacy and safety of CTX110, its wholly-owned alloge

23-10-2020

Tyber Medical's foot and ankle plating systems: USFDA 510(k) clearance

 

Tyber Medical LLC, a leading orthopedic device manufacturer, received a US Food and Drug Administration (FDA) 510(k) clearance for foot and ankle plating systems. It covers over 42 d

23-10-2020

Positive data for its COVID-19 vaccine candidate, CVnCoV from preclinical study : CureVac

 

CureVac N.V., a clinical-stage biopharmaceutical company, declared positive data of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters from preclinical st

17-10-2020

Use of pain and fever medication in pregnancy’s second half could lead to complications: US FDA warning

 

The USFDA (Food and Drug Administration) releases a Drug Safety Communication regarding labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). 

NSAIDs such

17-10-2020

Comprehensive eye care accounts for one-fifth of the global burden of blindness: need of the hour in India

 

India has one-fifth of the worldwide burden of blindness; hence, comprehensive eye care is the need of the hour, especially children’s eye health, according to experts, specifi

17-10-2020

Steripath Micro Initial Specimen Diversion Device: Magnolia Medical

 

Magnolia Medical Technologies Inc, a medical device company, launched the new Steripath Micro Initial Specimen Diversion Device.

Micro is the first US FDA 510(k)-cleared devi

17-10-2020

Anavex's Phase 2 proof of concept study of ANAVEX2-73 for Parkinson's disease dementia announces positive results

 

Anavex Life Sciences, a clinical-stage biopharmaceutical company, released results from the proof of concept phase 2 controlled trial evaluating the efficacy, safety, and tolerabilit

16-10-2020

COVID-19 makes access to healthcare difficult for Haemophilia patients

 

As the national government's primary focus shifted towards COVID-19, the emphasis on healthcare resources, infrastructure, and professionals to treat various other deadly diseases an

16-10-2020

Novel mitral valve repair technology may come up from Medtronic and Foundry collaboration

 

The global medical technology company, Medtronic, collaborated with a medical device company incubator, The Foundry, to bring up a novel transcatheter mitral repair technology (TMVr)

16-10-2020

Rapid diagnosis of Sickle Cell Disease may now be possible using a new Ultrasound device

 

The University of Colorado researchers have come up with a novel test based on ultrasound technology to detect sickle cell disease. The miniature size of the device, its swift mechan

16-10-2020

Access to tuberculosis services remains a challenge: WHO report

 

A report from WHO notifies that access to Tuberculosis (TB) services remains a challenge, and without urgent action and investments, global targets for treatment and prevention will

15-10-2020

Abbott Healthcare brings its Heart Rhythm Management Devices ICD, CRT-D to India

 

Abbott Healthcare introduced its new heart rhythm management devices, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronisation Therapy Defibrillator (CRT-D) in Indi

15-10-2020

FDA issues final guidelines containing biocompatibility draft on Nitinol devices

 

After reviewing feedback from its advisory committees, AdvaMed and Cook Medical, FDA has concluded the guidelines pertaining to nonclinical assessment of medical devices containing N

15-10-2020

Tiny Robots designed for targeted drug delivery to Colon and Tissue sampling

 

Researchers at Purdue University have devised externally controlled tiny robots to precisely deliver the drugs at the targeted area. An external magnetic field is used to control the

13-10-2020

Semi-Autonomous Colonoscopy using a Robotic Probe is now possible

 

The University of Leeds researchers have come up with a robotic system to help physicians or nurses perform colonoscopies. It uses magnets for guiding the probe through the body. As

10-10-2020

"Mann Talks" initiative to counsel individuals on mental health, free of cost

 

An initiative to build mental strength, "Mann Talks," was launched on October 10, at World Mental Health Day commemoration. The initiative aims to empower individuals suffering from

09-10-2020

ZEUS ELISA SARS-CoV-2 IgG test system gets EUA approval from USFDA

 

US Food and Drug Administration (US FDA) granted Emergency Use Authorization (EUA) to ZEUS Scientific's ELISA diagnostic test. The test is used to detect IgG antibodies to the SARS-C

08-10-2020

USFDA parameters to be used for assessing patients with COVID-19 symptoms for clinical trials

 

Medical Experts may follow US FDA set norms to evaluate the candidature of individuals with COVID-19 symptoms for clinical trials. The US FDA devised guidelines are being used as ref

08-10-2020

Many countries witnessing disruption in mental health services due to COVID-19: WHO

 

Even as the mental healthcare demand is increasing worldwide, 93% of the countries are witnessing disruption in the critical mental health services due to COVID-19. In a survey condu

08-10-2020

Azure pacemaker with BlueSync technology launched by Medtronic

 

Medtronic plc's Indian subsidiary India Medtronic Private Limited, launched the Azure pacemaker with BlueSync technology. It is designed to communicate seamlessly with patient's smar

08-10-2020

4D Pharma's Blautix shows positive results from the phase II BHT-II-002 trial related to irritable bowel syndrome

 

Blautix, a single strain Live Biotherapeutic from 4D pharma plc for treatment of irritable bowel syndrome (IBS), shows promising results from its phase II BHT-II-002 trial.

I

08-10-2020

Launch of Pressurized Metered Dose Inhaler in India for COPD Patients: Zydus Cadila

 

Zydus Cadila launched India's first pressurized Metered Dose Inhaler (pMDI), ForglynpMDI, for Chronic Obstructive Pulmonary Disease (COPD) patients in India. With a price tag of Rs.

06-10-2020

Positive results of phase III HAWK and HARRIER trials of Beovu to treat wet AMD: Novartis

 

Novartis declares positive results of the phase III HAWK and HARRIER clinical trials in wet age-related macular degeneration (AMD) at the EURETINA 2020 virtual congress.

AMD

06-10-2020

"National Clinical Management Protocol" for COVID-19, based on Ayurveda and Yoga released by the Health Minister

 

Dr Harsh Vardhan, Union health minister, recently showcased National Clinical Management Protocol based on Ayurveda and Yoga for COVID-19 management. Shripad Yesso Naik (the Minister

05-10-2020

Ashtel Studios recalls its sanitizers for food like packaging with Iconic images

 

Ashtel Studios issued a recall notice containing product destruction directions for the hand sanitizer manufactured and distributed by it. The packaging of sanitizer pouches have ima

03-10-2020

Integration of Ayush Grif with NDHM

 

The Ministry of AYUSH recently endorsed integrating its digital platform, Ayush Grid, with the National Digital Health Mission (NDHM). The final round of discussions between the Ayus

03-10-2020

Timely screening of critical diseased like breast cancer and TB affected by Corona pandemic: Fujifilm

 

The COVID-19 pandemic requires priority diagnosis and treatment of symptomatic patients. The pandemic has sent the national health infrastructure for a toss as the government is dedi

03-10-2020

SyntheticMR to integrate SyMRI in GE Healthcare's platform

 

SyntheticMR has collaborated with GE Healthcare to merge its MRI solution SyMRI in GE's platform. The newly integrated platform may provide quicker workflows and complete physiologic

03-10-2020

WaveWriter Alpha SCS from Boston Scientific will now be available in Europe

 

Almost the entire range of WaveWriter Alpha Spinal Cord Stimulator (SCS) Systems was officially launched in Europe by Boston Scientific, a global medi-tech giant. It includes four MR

03-10-2020

Japan PMDA approved Itamar Medical’s WatchPAT 300 home sleep apnea testing device

 

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved the Itamar Medical's WatchPAT 300 Home Sleep Apnea Testing (HSAT) device for commercial launch, effective September

01-10-2020

Positive Results of Innovational Phase 3 PH1 Trial: Alnylam

 

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, posts positive results from the pediatric Phase 3 (ILLUMINATE-B) study of lumasiran, an investi

01-10-2020

Positive Results of Innovational Phase 3 PH1 Trial: Alnylam

 

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, posts positive results from the pediatric Phase 3 (ILLUMINATE-B) study of lumasiran, an investi

01-10-2020

Pooled Analysis of Data from two Phase 3 Clinical Trials of Upneeq™ (for Acquired Ptosis): JAMA Ophthalmology

 

Osmotica Pharmaceuticals plc's subsidiary RVL Pharmaceuticals Inc. stated that its novel medicine Upneeq's Phase 3 clinical trial data was published by JAMA Ophthalmology. Pooled ana

01-10-2020

ICMR approves Biocard Pro COVID-19 Antigen Rapid Testing Kits from Trivitron

 

Trivitron Healthcare Private Limited received approval from the Indian Council of Medical Research (ICMR) to launch its 'Biocard Pro COVID-19 Rapid Antigen' testing kits commercially

29-09-2020

Airborne transmission of SARS-CoV-2:

 

Researchers at the University of Georgia are supporting the theory of - Airborne transmission of COVID-19 in enclosed spaces.

According to their studies, they distinctly supp

29-09-2020

CardioQuip's heater-cooler device could cause infection, warns FDA.

 

FDA issued a notice warning the healthcare providers about the risk of infection through using CardioQuip’s heater-cooler device. The device is used to control patients' body t

28-09-2020

Abbott's latest CGM device, Libre 3, receives CE mark

 

FreeStyle Libre 3, the latest continuous glucose monitoring (CGM) device from Abbott, received the CE mark, thereby paving the way for its commercial launch in the European market. A

27-09-2020

Equine Biotech, an IISc start-up, comes up with a Pocket-Friendly RT-PCR kit

 

Equine Biotech, a start-up of IISc (Indian Institute of Science) students, has developed a novel and affordable Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) diagnostic ki

25-09-2020

University of Illinois partners with Aequs to bring up mechanical resuscitator

 

Aequs Force Consumer Products Pvt. Ltd. is coming up with a medical-grade and affordable mechanical resuscitator, AQovent. The company, in collaboration with the University of Illino

25-09-2020

SeaSpine launches WaveForm C 3D-printed interbody implant system

 

WaveForm C Interbody Implant System was launched commercially by SeaSpine. The global medical technology giant plans to launch four more devices by mid-2021.

The novel WaveFo

24-09-2020

KardiaMobile 6L, clinically-authenticated exclusive ECG device launched in India by AliveCor

 

KardiaMobile 6L, the best personal electrocardiogram (ECG) device with US FDA approved ECG technology, was launched by AliveCor in India. It has proven efficacy in detecting atrial f

24-09-2020

Vela Diagnostic: ViroKey SARS-CoV-2 RT-PCR test v2.0 gets US FDA approval for emergent situations

 

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to ViroKey SARS-CoV-2 RT-PCR Test v2.0 of Vela Diagnostics. Certain laboratories certified und

24-09-2020

RTI Surgical's DAC Plate gets USFDA approval under section 510(k)

 

USFDA granted 510(k) clearance to the RTI Surgical’s Dynamic Active Compression (DAC) plate. Post-approval, the DAC plate has become the first-ever product that may be used to

23-09-2020

Wipro’s Chitra Air Bridge to be available for breathing assistance anywhere with Wipro 3D and GenWorks partnership

 

Affordable breathing assistance medical device, Chitra Air Bridge, may become available for all as Wipro 3D ties up with GenWorks Health.

As the COVID-19 cases are surging in

22-09-2020

AR-12 Cancer drug- Aids in fight against SARS-CoV-2:

 

AR-12 is a powerful drug which has been studied considerably by the Researchers. This drug is an anti- cancer drug which also tends to have anti- viral function. This drug administer

21-09-2020

Tata group forays into Medical Diagnostics as DGCI approves its economical Covid-19 Test Feluda

 

The Drug Controller General of India (DCGI) approved the commercial launch of the low-cost COVID-19 test, FELUDA, under strict ICMR guidelines. The test designed by CSIR (Council of

09-09-2020

Enerzair Breezhaler shows promising results in reducing moderate to severe asthma: Novartis

 

A single high-dose in a day of Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]), from Novartis, is claimed to reduce moderate to

08-09-2020

Aesthetic medical devices' launch, NuEra Tight with FocalRF for personalized body sculpting treatments: Lumenis

 

The largest energy-based medical device company, Lumenis Ltd., announces the launch of revolutionary NuEra Tight with FocalRF technology, in the Middle East and Europe for body sculp

05-09-2020

Positive results of Vadadustat to treat anemia due to CKD in adult patients from PRO2TECT phase 3 program: Akebia Therapeutics

 

Akebia Therapeutics Inc, a biopharmaceutical company, declared positive results of vadadustat, oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) from PRO2TECT, the

05-09-2020

Elicited Antibody Response, with no Serious Adverse Events In phase 1/2: Russian Vaccine for preventing COVID-19 infection

 

The paper published in Lancet states the findings of two open-label, Russian non-randomized phase 1/2 trials (Sputnik V) looking at a freeze-dried formulation and a frozen formulatio

04-09-2020

Non-invasive medical instruments for pain relief in India : OSKA India


OSKA Wellness launched 'OSKA Pulse'; PEMF (Pulsed-Electromagnetic-Field-Therapy) technology-enabled products, in India.

The company is the first enab

04-09-2020

Remarkable reduction in LDL-C, established in Phase 1/2 Clinical Study: Tafolecimab

 

SUZHOU and SAN FRANCISCO, China - Researchers have declared that Tafolecimab (IBI306), an innovative PCSK9 inhibitor (recombinant fully human monoclonal antibody) in Phase 1 (NCT0336

02-09-2020

Failure to meet primary and secondary endpoints in phase 3 trial of Kevzara to treat COVID-19: Sanofi

 

Sanofi is unsuccessful in meeting its primary endpoint and key secondary endpoints in the global phase 3 trial investigating intravenously administered Kevzara (sarilumab) at a 200 m

02-09-2020

Roche's Cobas 6800/8800 HIV-1/HIV-2 Qualitative Test for HIV/AIDS detection: US FDA approval

 

US Food and Drug Administration (FDA) approval awarded to Roche for the cobas 6800/8800 HIV-1/HIV-2 Qualitative Test in the US. The healthcare professionals may have a single result

01-09-2020

High consistency in lowering LDL-C with investigational inclisiran: Novartis’ phase III ORION-10 and -11 trials

 

Novartis declares results of pooled data from the phase III ORION-10 and -11 trials from a post-hoc analysis studying patients' specific responses on low-density lipoprotein choleste

01-09-2020

Positive results from phase 3 TRILOGY 2 study of CaPre for severe hypertriglyceridemia: Acasti Pharma

 

Acasti Pharma, a biopharmaceutical company, declares positive results from phase 3 TRILOGY 2 study evaluating the efficacy, safety, and tolerability of CaPre (omega-3 phospholipid) i

01-09-2020

Positive results from phase III trial (EMPEROR-Reduced) of empagliflozin in heart failure patients: Boehringer Ingelheim

 

Boehringer Ingelheim declares positive results from the EMPEROR-Reduced phase III trial of empagliflozinin in heart failure patients with reduced ejection fract

31-08-2020

Foundation One Liquid CDx (a comprehensive pan-tumor liquid biopsy test): US FDA approval

 

Roche received US Food and Drug Administration (FDA) approval for Foundation One Liquid CDx, Foundation Medicine’s comprehensive pan-tumor liquid biopsy test for solid tumor pa

31-08-2020

Significant efficacy & safety of diabetes drug, dapagliflozin in CKD patients: AstraZeneca's phase III DAPA-CKD study

 

AstraZeneca India declares the complete results from the clinical trials of its latest diabetes drug, dapagliflozin. It reduces chronic kidney disease (CKD) progression in patients w

31-08-2020

Release of draft guidance on PROs for device manufacturers: FDA

 

The US Food and Drug Administration (FDA) released a new draft guidance for Device manufacturers for the selection of patient-reported outcome (PROs) instruments in clinical&nbs

29-08-2020

Sanitizers packed in containers look like food or drinks: warns USFDA

 

The US Food and Drug Administration (FDA) signals consumers regarding alcohol-based hand sanitizers packaged in containers imitating food or drinks. If ingested, it may put consumers

29-08-2020

Positive results from GSK’836 for chronic hepatitis B treatment from phase 2a data: GSK

 

GSK declares that GSK’836 (GSK3228836), an investigational antisense oligonucleotide (ASO), shows a significant decrease in hepatitis B virus DNA and hepatitis B surface antige

28-08-2020

Guidelines to conduct COVID-19 screening in TB patients: Health ministry

 

The Union health ministry releases guidelines stating that tuberculosis (TB) screening will be done for all COVID-19 positive patients and COVID-19 screening will be done for all TB

28-08-2020

New workflow and imaging enhancements for Kodex-EPD cardiac mapping and imaging system for heart rhythm disorders: Philips

 

Royal Philips announces new imaging and workflow enhancements for its novel Kodex-EPD cardiac imaging and mapping system. The system treating a common heart rhythm disorder,&nbs

28-08-2020

Launch of High-Flow Oxygen Therapy Device, Noccarc H210 for critical COVID-19 patients: Nocca Robotics


Nocca Robotics Pvt Ltd, of SIIC, IIT Kanpur, launched a clinically validated and certified High- Flow Oxygen Therapy Device for COVID-19 patients. The device

28-08-2020

Abbott Rapid Covid-19 Test Kit For Emergency Use: USFDA Nod

 

Abbott receives Emergency Use Authorization (EUA) for its BinaxNOW COVID-19 Ag Card rapid test for COVID-19 infection detection from the U.S. Food and Drug Administration (

27-08-2020

Phase III ASCEMBL study of bosutinib versus asciminib meets primary endpoint: Novartis

 

Novartis' phase III ASCEMBL study met its primary endpoint of major molecular response
(MMR) rate at 24 weeks for asciminib (ABL001) vs bosutinib at statistically significant

27-08-2020

Ban Lifted on export of PPE medical coveralls & 2/3 ply surgical masks: DGFT

 

The Directorate General of Foreign Trade (DGFT) lifts ban on PPE medical coveralls and all masks export varieties, except N95 masks.

DGFT, on August 25, 2020, revised the exp

27-08-2020

FDA approves Foundation Medicine's pan-tumor biopsy test

 

The US Food and Drug Administration (FDA) approves Foundation Medicine's pan-tumor liquid
biopsy test FoundationOne Liquid CDx.

The kit's assay uses blood samples to eva

27-08-2020

Bristol Myers Squibb unsuccessful in achieving primary endpoint in phase 3 IDHENTIFY study of IDHIFA in relapsed or refractory AML

 

Bristol Myers Squibb did not meet the primary endpoint of overall survival (OS) in phase 3 IDHENTIFY study evaluating IDHIFA (enasidenib) plus best supportive care (BSC) versus&

26-08-2020

India’s first-ever rapid diagnostic test kit for Covid-19 gets ICMR approval


Delhi based Oscar Medicare Pvt. Ltd. that manufactures various in-vitro diagnostic kits have developed a simple, single prick rapid testin

24-08-2020

FDA Clearance to Home use Intravaginal Device For Stress Urinary Incontinence (SUI)

 

The U.S. Food and Drug Administration (FDA) has issued clearance for Flyte™, intravaginal in-home, non-invasive, device meant to strengthen the pelvic floor muscles, which help

24-08-2020

Novartis unsuccessful in achieving primary endpoint in phase III COMBI-i study evaluating Tafinlar and Mekinist combination with spartalizumab

 

Novartis failed to meet its primary endpoint of investigator-assessed progression-free survival in phase III COMBI-i study for evaluation of investigational immunotherapy spartalizum

23-08-2020

High-flow nasal oxygen (HFNO) method seems to be crucial during COVID

 

HFNO has become synonymous with a bridge between mask and ventilator. It is replacing the invasive mechanical ventilation for treatment of respiratory distress in Covid-19 patients.

22-08-2020

USFDA holds back plasma therapy for treatment of COVID- 19

 

The USFDA disapproves plasma therapy as an emergent weapon for treating COVID -19 as reported on 19 August, 2020. However, currently the plasma therapy is being tested globally

22-08-2020

The US-based firm, Advanced Penetration Technology, LLC. found a USFDA approved OTC ointment useful in treating viral infections including Covid-19

 

FDA registered a non- prescription over the counter ointment possessing virucidal activity has the potential to kill and treat viral infections including SARS-CoV-2, the virus respon

22-08-2020

Bharat Biotech all set to conduct the Phase I and II clinical trials for its COVID-19 vaccine ‘Covaxin’, receives green signal from CDSCO

 

The Drug Controller General of India gave approval to Bharat Biotech to test its first Covid-19 vaccine via the skin through intradermal delivery.  The company would now conduct

22-08-2020

Guidelines on safe ophthalmology practices during COVID-19: Health ministry

 

The Union health ministry issued guidelines on safe ophthalmology practices in COVID-19. The guidelines describe the preventive and responsive measures to minimize and avoi

22-08-2020

Leven Medical: India-Dutch collaborative startup announces smart ventilators with AI ML


The smart ventilators can auto adjust patient's oxygen flow. In emergent cases, these send alerts to the concerned medical staff and to family members. The s

22-08-2020

Oliceridine approval for Acute Severe Pain as IV Use In Hospitals: FDA

 

The U.S. Food and Drug Administration has approved Olinvyk (oliceridine), an opioid agonist to Trevena, Inc. for moderate to severe acute pain management for intravenous use in hospi

21-08-2020

ICMR collaborates with Serum Institute of India to develop a promising experimental corona virus vaccine to combat COVID-19 scenario

 

Clinical trials are the research-based studies conducted on human volunteers to evaluate a medical and therapeutical intervention by determining its effects in human health outc

21-08-2020

New Guidelines by WHO for use of masks for children during the COVID-19 pandemic.

 

The World Health Organization along with UNICEF advises the use of masks for children to protect themselves during the COVID-19 pandemic. Since the disease has evolved to be asymptom

20-08-2020

Smart wearable devices may detect COVID-19 even before the symptoms: Fitbit

Fitbit, a leading manufacturer and marketer of health-tracking watches, launched a study aiming to create an algorithm to detect COVID-19 before symptoms appeared. Out of the 100,000 enrol

11-08-2020

Heavy Metal Contamination found in Fishes from the seas surrounding Turkey

 

Fish is the most important source of protein and is included as an important component of cuisine not only in the coastal areas but also in towns.

As per the survey conducted

04-08-2020

USFDA revokes the emergency use of hydroxychloroquine (HCQ) to treat COVID-19 due to high risk of heart rhythm problems

 

USFDA cautions health care professionals and patients against the use of hydroxychloroquine for treating COVID-19 patients.  Based on the various data analysis, FDA recalls the

12-03-2020

USFDA grants CINtec PLUS Cytology test of Roche for screening of cervical cancer


Roche was awarded by US Food and Drug Administration (FDA) grant for CINtec PLUS Cytology for the 1st biomarker-based triage test for women whose p

12-03-2020

AIOCD requests government to terminate illegal market of medicines through online pharmacies

 

A request has been brought to notice by All India Organization of Chemists and Druggists (AIOCD) to the government for terminating illegal marketing of medicines through on

11-03-2020

CRO contract gained by Novotech for Komipharm coronavirus Covid-19 clinical trial in South Korea

 

For the Komipharm International clinical trial of Panaphix, a leading CRO, Novotech, has been chosen as the trial has the potential treatment for coronavirus - Covid-19. Ko

11-03-2020

Towards growing burden of mental health disorders in India, An MoU between Indo-US signed for mental healthcare points

 

The present memorandum of understanding (MoU) between the US and India for mental healthcare identifies the growing burden of mental health disorders in India. On his first

11-03-2020

Warning of Cancer can be done by Blood test for microbial DNA

 

A new study advertised in the journal Nature on March 11, 2020, could change the currently held aspects on cancer causation and diagnosis. The researchers have come up with

10-03-2020

Genetic test could assist doctors in identification of patients with ultra-high risk multiple myeloma

 

A novel genetic test could assist doctors in picking out patients with the bone marrow cancer multiple myeloma that is at 'ultra-high risk' of their cancer progressing aggr

09-03-2020

Laboratories of BioReference to launch coronavirus disease test

 

An OPKO Health company, BioReference Laboratories, Inc., declared regarding offering a test for the novel coronavirus (2019-nCoV) which is a contagious virus that leads to

09-03-2020

XCR Diagnostics receives US patent for technology that expedites testing and recognition of infectious diseases

 

A molecular diagnostics company known as XCR Diagnostics has been granted a patent by the United States Patent and Trademark Office (US PTO) for its technology that expedit

08-03-2020

Silfradent Srl received warning letter


An inspection has been performed at firm located in Santa Sofia, Forli-Cesena, Italy, on July 29, 2019 to August 1, 2019, an investigator from the

07-03-2020

Regulation of Medical device in Japan and India discussed at 4th India-Japan Medical Products Regulatory Symposium

 

Regulatory and Clinical trial supports for innovative drug development in Japan, latest upbeat of clinical trial needs in pre and post marketing phase in India, and medical

07-03-2020

Karnataka government allocates Rs10,122 crores for health, determined to strengthen hospital infrastructure

 

Government of Karnataka has allocated Rs.10,122 crore for health & family welfare in its financial budget for year 2020-21. The government has declared a slew of suppor

07-03-2020

Newly created mobile app aids in reduction of pain in osteoarthritis patients

 

By conducting a few simple physical exercises routinely, and getting data about their disease regularly, 500 osteoarthritis patients were able to on average halve their pai

07-03-2020

Excillum introduces the NanoTube N2 - the X-ray resolution revolution continues with higher voltage and more power

 

Excillum which is Stockholm-based Company declared the introduction of a new generation high-resolution X-ray tubes.

The Excillum NanoTube N2 110 kV and N

07-03-2020

Delivery of Curcumin effectively into cells via tiny nanoparticles

 

For decades, curry lovers have sworn by the anti-inflammatory characteristics of turmeric, but its active compound, curcumin, has long antagonized scientists hoping to vali

07-03-2020

Bio-ADM of Sphingotec can reliably assist physicians in recognizing high-risk sepsis patients

 

Diagnostics company SphingoTec GmbH announced on new information on the utility of endothelial function biomarker bioactive Adrenomedullin (bio-ADM®). The data demonstr

06-03-2020

Firms prepares to meet huge demand of sanitizers and masks

 

As Covid-19 patients continue to rise in India, sanitizers and masks have started to vanish from shelves with several stores and chemists in larger cities marketing the coveted

06-03-2020

Gujarat FDCA combines with USP for knowledge sharing on drug standards

 

The Gujarat Food and Drug Control Administration (FDCA) has joined hands with United States Pharmacopoeia (USP) for knowledge sharing on drug standards followed in the US.

06-03-2020

SCTIMST creates intracranial flow diverter stent for treatment of aneurysms of blood vessels of brain


The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, which is an institute of national importance, has c

06-03-2020

CryoLife receives CE Mark for E-vita Open NEO hybrid stent graft


A leading cardiac and vascular surgery company known as CryoLife, Inc., committed on aortic disease, declared that it has achieved CE Mark for the E-vit

06-03-2020

Recalling of Alaris System Infusion Pumps by Becton Dickinson (BD) CareFusion 303 Inc.

 

The Alaris System is vital signs monitoring system and an infusion pump. The infusion pumps deliver medications, fluids, blood and blood products into the body of a patient

06-03-2020

Coronavirus kits to be marketed only when prescribed by doctor, as per FDA

 

The Maharashtra Food and Drug Administration (FDA) has ordered chemists to market coronavirus kits only when it is prescribed by the doctor, as per the official statement o

06-03-2020

Novel AI system can access endoscopic observations of ulcerative colitis with accuracy

 

Evaluations of patients with ulcerative colitis (UC), which is a kind of inflammatory bowel disease, are usually performed via histology and endoscopy. But now, researchers

05-03-2020

USFDA approves rare pediatric disease status to Acadia and Neuren's trofinetide for treatment of rett syndrome

 

A biopharmaceutical company, Acadia Pharmaceuticals and Neuren Pharmaceuticals Limited declared that the US Food and Drug Administration (FDA) approved Rare Pediatric Disease (RPD) d

05-03-2020

Draft Medical Devices Bill for stakeholders review soon will be circulated by Niti Aayog


To talk about the regulatory vacuum and issues of patient safety in medical devices, Niti Aayog is likely to spread a draft of the Medical Devices Bill for s

05-03-2020

Merck introduces LANEXO system to increase productivity of scientists in laboratory


A leading science and technology company, Merck, inaugurate its LANEXO Lab Inventory, safety and compliance management system which is a new digital lab

05-03-2020

Elecsys GALAD score of Roche gains US FDA breakthrough device designation to diagnose HCC


Roche declared that the US Food and Drug Administration (FDA) has approved Breakthrough Device Designation to the Elecsys GALAD score. This algorithmic score

05-03-2020

As per WHO, connection between Coronavirus and currency notes

 

The World Health Organization (WHO) has suggested people to neglect using currency notes to prohibit the spread of the COVID-19 virus or the novel coronavirus that has caused a

05-03-2020

Zydus Cadila receives DCGI approval for first drug in the world for treatment of liver disease

 

Zydus Cadila has received permission from the Drug Controller General of India (DCGI) for its novel drug application for Saroglitazar for treatment of a particular condition of

05-03-2020

An arthritis drug could be the resolving concern of everyone for treating Coronavirus

 

A ten-year-old drug utilized for treatment of inflammation in arthritis patients could be the answer to the fears of the coronavirus throughout the world.

An anti-inflam

05-03-2020

DCGI orders state DCs to execute incorporation of SJS as ADR in PIL of Chloroquine drug

 

Drugs Controller General of India (DCGI) has ordered state drug controllers (DCs) to assist manufacturers in executing incorporation of Stevens-Johnson syndrome (SJS) as an adve

04-03-2020

For the development of CAR-T cell therapy at affordable price in India, DBT

 

For the development of CAR-T cell therapy at affordable price in India, DBT invites concept proposals Concept proposals have been invited by the Department of Biotechnology (DBT

03-03-2020

SCTIMST creates device for non-surgical closure of atrial septal defect in heart

 

An institute of national importance, the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, has created a nickel-titanium allo

03-03-2020

An App was developed by researchers for Predicting Risk of Preterm Birthq

 

An enhanced mobile phone app will aid in identifying women who require special treatments at the right time and lower the emotional and financial burden on families and the

03-03-2020

Karnataka government secures 630 beds as isolation wards in government hospitals & 1,689 beds in private medical centres

 

Karnataka govt. has stated that around 630 beds have been secured as isolation wards in government hospitals, while 1689 beds have been secured as isolation wards in privat

03-03-2020

Using Virtual Reality, Patients may Successfully Carry out Physiotherapy at Home

 

Virtual reality (VR) could assist in physiotherapy for patients to complete their exercises at home successfully thanks to WMG’s researchers, University of Warwick, w

03-03-2020

Union health ministry executes NPHCE for approachable healthcare to senior citizens

 

In order to give approachable healthcare to the elderly the Union health ministry is executing National Programme for Health Care of the Elderly (NPHCE) at various levels o

03-03-2020

CDC and USFDA take action to enhance access to respirators, involving N95s for health care personnel

 

The Centers for Disease Control and Prevention and the US Food and Drug Administration (FDA) took steps to make more respirators, including certain N95s, available to healt

02-03-2020

US FDA furnishes new policy for certain labs trying to develop diagnostic tests for coronavirus

 

As an involvement in the ongoing and aggressive commitment of US Food and Drug Administration to address the coronavirus outbreak, the agency furnished a new policy for cer

02-03-2020

High Sugar Diet throughout Pregnancy may Impact Metabolic Health after Pregnancy

 

High sugar diet throughout pregnancy may result in enhanced progesterone levels and changes in the dopamine system and may have serious, long-term health complications for

02-03-2020

Raipur Hospital receives State-Of-The-Art Pathology Lab

 

TS Singh Deo, Chhattisgarh Health Minister launched a state-of-the-art integrated diagnostic laboratory called 'Hamar Lab' at the government hospital there on Friday. The l

29-02-2020

Avanos receives FDA clearance for COOLIEF Radiofrequency system


Avanos Medical has gained clearance from the US Food and Drug Administration (FDA) for selling its 80W COOLIEF Radiofrequency (RF) system for neuro

29-02-2020

Cynosure gained FDA clearance for RF micro-needling device

 

A US-based medical device company known as Cynosure is committed on medical aesthetics, has gained regulatory clearance from the US Food and Drug Administration (FDA) for i

29-02-2020

FDA grants heart and lung support system of Novalung

 

The US Food and Drug Administration (FDA) has granted Novalung, a heart and lung support system created by Fresenius Medical Care North America (FMCNA) to treat acute respi

29-02-2020

For Critically-ill Patients, FDA grants Heart and Lung Support System

 

Novalung® has been cleared by the U.S. Food and Drug Administration (FDA) which is a heart and lung support system to treat acute respiratory or cardiopulmonary failure

28-02-2020

FDA approves breakthrough status to RESPMETER device of Altair Medical

 

RESPMETER wearable biosensor device of Altair Medical has been granted Breakthrough Device status by the US Food and Drug Administration (FDA) in an effort to manage the gl

28-02-2020

FDA awards marketing authorization for Fragile X Syndrome test

 

The US Food and Drug Administration (FDA) has awarded marketing authorization to Asuragen for its AmplideX Fragile X Dx and Carrier Screen Kit to assist in identifying Frag

24-02-2020

In Mumbai, Aditya Jyot Foundation to perform 5000 free cataract and retina surgeries for low income groups

 

For Twinkling Little Eyes, Aditya Jyot Foundation in association with Bajaj Auto Ltd will be performing 5000 free cataract and retina surgeries for low income groups.

24-02-2020

First Genetic Test for Diagnosing Fragile X Syndrome granted by FDA

 

The U.S. Food and Drug Administration today granted marketing of the first test for the detection of a genetic condition known as Fragile X Syndrome (FXS), the most common known

23-02-2020

New Device engineered for treatment of Intracranial Aneurysms achieved CE Mark Approval

 

A new device to treat of intracranial aneurysms, Contour Neurovascular System has achieved European CE Mark approval, declared medical device company Cerus Endovascular. Th

23-02-2020

Director of AIIMS highlights precautions For Swine Flu and severe Viral Fever

 

Director of All India Institute of Medical Sciences (AIIMS), Dr Randeep Guleria on Friday described about some precautions to prohibit the disease due to widespread cases o

23-02-2020

Majority of pediatricians provide assistance in national vaccination program despite obstacles

 

Despite bureaucratic obstacles, the vast majority of pediatricians want to keep enrolling in a national program that offers vaccinations at no cost to children who are on u

22-02-2020

As per the Ministry of Chemical and Fertilizers, Violation of Price Capping of Coronary Stent has been done to Attract NPPA Action

 

The Ministry of Chemical and Fertilizers recently announced the Parliament that if any violation of price capping relating to Coronary Stents is found by the National Pharm

22-02-2020

As per ICRA, medical devices to be brought under Drugs Act to assist in medical device regulation effectively

 

ICRA has co

22-02-2020

Hospitals which are civic-run in Mumbai hit badly due to non-supply of crucial life-saving drugs

 

Mumbai hospitals which are civic-run are scuffling to regulate consistent supply of crucial life-saving medicines as 150 stockists from Maharashtra have halted supplies to

20-02-2020

Novacyt, an Anglo-French Company introduces CE-IVD Marked Novel Coronavirus Diagnostics Test

 

Novacyt, an Anglo-French Company specializes in clinical diagnostics currently declared that its molecular diagnostics division, Primerdesign, has introduced its CE-Mark mo

19-02-2020

Continuous Wearable BP & Vital Signs Monitor with ECG Patch

 

A Wireless Vital Signs Monitor and Continuous Blood Pressure & with ECG Patch has been commercialized for use of patients. This is developed by Caretaker Medical, a lea

19-02-2020

For Better Management of Lung Diseases, use New X-Ray Technology

 

Scholars at Monash University have created radical non-invasive X-ray technology to aid in diagnosis, treatment and management in respiratory lung diseases. The technology,

14-02-2020

FDA grants Eko cardiology technology advancement

 

Prior this month, Eko, an artificial intelligence (AI) digital health company, was approved FDA approval for its latest cardio-technology.

The US-based co

14-02-2020

Prediction of Death Due to Stroke and Heart Attack can be done by AI with Cardiac MRI

 

University College London Researchers have utilized artificial intelligence for the first time to instantly and precisely measure blood flow. Utilization of Artificial inte

14-02-2020

Manipur Ayush department directs Ayush hospitals to circulate ‘Arsenicum Album 30’ as preventive measure against nCoV infection

 

Following the health advisory furnished by the Union Ayush Ministry recently suggesting homeopathy medicines as effective preventive medication of the novel coronavirus (nC

13-02-2020

Health ministry furnishes notification to maintain all medical devices under D&C Act from April 1, 2020

 

Union health ministry has announced that all medical devices will now be maintained under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for

13-02-2020

FDA approves 510(k) clearance to MRI system of Hyperfine Research

 

The US Food and Drug Administration (FDA) have approved 510(k) clearance to bedside Magnetic Resonance Imaging (MRI) system of Hyperfine Research.

The fir

13-02-2020

Surgical System of TransEnterix’s Senhance receives CE Mark approval

 

Medical device company TransEnterix has obtained CE Mark approval for an extended indication of the Senhance Surgical System for treatment of paediatric patients weighing a

13-02-2020

FDA grants mobile app of Orthofix for bone growth stimulators

 

Orthofix Medical declared today that it gained FDA approval for its STIM onTrack mobile app version 2.1 for utilization with its bone growth stimulators.

13-02-2020

Progression of Parkinson's disease can be predicted by simple Blood test

 

Researchers have observed that a blood test for cell senescence biomarkers and inflammatory may be a reliable predictor of cognitive decline, involving identifying those wh

13-02-2020

As per Lancet, None Transmission of New Coronavirus Intrauterine Vertically From Mother to Child

 

There is no proof of intrauterine vertical transmission of novel coronavirus from mother to child, as per the new study.

Researchers evaluated intrauterin

12-02-2020

FDA approves Surfacer System De Novo clearance of Bluegrass Vascular

 

The US Food and Drug Administration (FDA) have approved a De Novo clearance to Surfacer Inside-Out Access Catheter System engineered by private medical technology company B

12-02-2020

Medical devices to be maintained as drugs

 

All medical devices marketed in the country will now be maintained as ‘drugs’, and come under the purview of the Drugs and Cosmetics Act. The government stated

12-02-2020

WHO coins Coronavirus As 'COVID-19'

 

The new coronavirus that has caused mortality over 1,000 people in China and morbidity more than 43,000 others globally has been coined 'COVID-19', the World Health Organiz

12-02-2020

Bringing MRI to Bedside in Stroke Patients using portable MRI

 

At current scenario patients have to move to a location of a high-field MRI device for diagnosis of stroke causing vital delay in diagnosis. However, Advancement in low-fie

11-02-2020

Novacyt tries Emergency Usage Approval for coronavirus test

 

Novacyt, a Biotech company has applied to the US Food and Drug Administration for the Emergency Usage Approval for its novel coronavirus (2019-nCoV) test, developed by its

11-02-2020

icometrix gains FDA approval for icobrain ep solution

 

icometrix has gained 510(k) clearance from the US Food and Drug Administration (FDA) for its icobrain ep solution.

Icobrain ep assists in identification o

11-02-2020

First medical device for usage in U.S by SA biotech cleared by FDA

 

Bluegrass Vascular Technologies has gained regulatory approval from the Federal Drug Administration to provide its medical device on the market in the U.S. roughly 9 years

11-02-2020

Update on Coronavirus, ICMR Gets Emergency CDSCO approval for Usage of Cocktail of Anti-HIV Drugs on NCoV Patients

 

In an important move to battle the epidemic, the Central Drug Control Organization (CDCSO) has provided an emergency grant to India Council of Medical Research (ICMR) to ut

10-02-2020

Marketing approval obtained by cardiac ultrasound software of Caption Health

 

Caption Health has gained authorization from the US Food and Drug Administration (FDA) for marketing its cardiac ultrasound software.

Caption Guidance, th

10-02-2020

FDA provides OTC clearance to INNOVO of Atlantic Therapeutics for SUI

 

The US Food and Drug Administration (FDA) have provided over-the-counter (OTC) clearance to INNOVO of Atlantic Therapeutics, a non-invasive and wearable device for stress u

10-02-2020

FDA breakthrough designation received by Aria CV for Its medical device to treat pulmonary arterial hypertension

 

A developer of medical devices, Aria CV, Inc., for treating Pulmonary Arterial Hypertension (PAH), today declared that they have secured from U.S. Food and Drug Administrat

28-01-2020

MRI-compatible products by Imricor receives CE mark approval

 

Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode get CE mark approval to conduct cariac catheter ablations using real-time MRI. Imricor is the first company to have car

28-01-2020

FDA 510(k) clearance to BioSticker

 

The BioSticker™ on-body sensor for scalable remote care by BioIntelliSense Inc. receives the FDA 510(k) clearance.

A new standard for remote patient monitoring is offer

20-01-2020

Health ministry furnishes reframed draft national policy to treat rare diseases

 

The Union health ministry has furnished the reframed draft National Policy to treat Rare Diseases (NPTRD), 2020. The ministry has invited views and comments from the stakeh

20-01-2020

New guidelines of IRDAI permit patients to take treatments from all Ayush hospitals irrespective of NABH or state level certifications

 

Arogya Sanjeevani which is the new standard health insurance policy, launched by the Insurance Regulatory and Development Authority of India (IRDAI) on January 1 this year aids 

18-01-2020

Indian Psychiatric Society opposes usage of Stem Cell Therapy in Psychiatric Disorders, Especially Autism

 

Marking that currently there is no research proof substantiating the claim of utilizing stem cell treatment to treat Psychiatric Disorders, the Indian Psychiatric Society (

18-01-2020

Maternity care to be more understanding in Maharashtra

 

18-01-2020

Defensive nature of cells against stress by cohesion

 

In a current study, scholars have been able to demonstrate how cell to cell contacts are important for the survival of human cells under protein-damaging conditions and str

18-01-2020

As virus spreads in China, India furnishes advisory

 

India has furnished a travel advisory for those visiting China and stepped up surveillance at airports at the event of an outbreak of coronavirus in China.

Following reports

18-01-2020

Health department to provide pulse polio vaccine to 2.28 lakhs children in Kozhikode

 

District collector Sambasiva Rao here on Friday stated that pulse polio vaccine will be given to 2,28,768 children up to five years in Kozhikode district during the immunization of p

18-01-2020

AI tool to recognize modifications in patients' mental health

 

Researchers, involving one of Indian-origin, have created an artificial intelligence (AI) tool that can precisely detect modifications in clinical states in voice data of p

18-01-2020

Study observes patients with newly diagnosed musculoskeletal pain are prescribed opioids more often than suggested

 

During their 1st physician visit, patients suffering from newly diagnosed chronic musculoskeletal pain are prescribed opioids more often than physical therapy, counselling,

17-01-2020

As the spread of superbugs, WHO alerts over lack of new antibiotics

 

The World Health Organization alerted on Friday that a urgent lack of new antibiotics was threatening efforts to tackle the spread of drug-resistant bacteria, which kill te

17-01-2020

Next-generation radiation therapy for cancer patients now in India

 

Indraprastha Apollo Hospital in New Delhi on Friday introduced the most advanced version of TomoTherapy Radixact X9, the smartest radiation therapy for the treatment of the

17-01-2020

Siemens reveals medical manufacturing centre in Bangalore

 

Siemens Healthineers which is a medical technology company has initiated its first manufacturing facility in Bengaluru, which will complement its existing R&D centre. T

17-01-2020

Novel 'smart' chair aids in correcting body posture from childhood


The concept of the current study is already submitted in the conference materials furnished by the French publishing house Atlantis Press, con

17-01-2020

Team discovers a way to eliminate GI device without the usage of endoscopy


Scholars at Massachusetts Institute of Technology (MIT) have potentially discovered a way to remove some of the endoscopic surger

17-01-2020

Fitness tracker devices demonstrate potential as predictors of flu outbreaks

 

Scholars at Scripps Research Translational Institute have discovered that fitness tracker devices – wearable tracker devices that calculate heart rate and sleep durat

16-01-2020

Patients of Organ transplantation in Telangana to receive complete healthcare

 

Patients of Organ transplantation in Telangana to receive complete healthcare package under Arogyasri scheme Telangana state govt. has determined to give better financial help t

16-01-2020

MoHFW furnishes National Policy for Rare Diseases

 

The govt. will give a financial support of up to Rs15 lakhs under its Rashtriya Arogaya Nidhi scheme for one-time treatment of rare diseases, as per the much awaited draft Rare Disea

16-01-2020

Sleep apnea remained untreated can enhance the risk of dying from heart disease

 

American Heart Month is February. Did you know that sleep apnea effects heart health? As per the American Academy of Sleep Medicine, nearly 30 million American adults are suffer

15-01-2020

To monitor unethical Practice, J&K to perform Prescription Audit at Govt. Hospitals

 

The Jammu and Kashmir administration is taking a series of measures to stop unethical and unfair practices in medical profession in Jammu Kashmir, as per the official spokesman who&n

14-01-2020

Medtronic gains CE Mark approval for InterStim products


Medtronic which is Irish medical device maker has secured CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads.

14-01-2020

Clearance of new AI system from FDA for spotting stroke


501(k) clearance has been granted to the US Food and Drug Administration (FDA) for radiology company Aidoc’s AI-based system for the recognition of lar

14-01-2020

Phagenesis gains FDA breakthrough green light for Phagenyx System for restoring swallowing


Phagenesis declared that it has secured breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control.

13-01-2020

Many went under Knee Replacement Too Late or Too Soon: All in the Timing

 

It's a question which pops in many aging Americans: Is it time for replacing my aching knee, or should I wait? New research indicates that for far too many patients, the procedure is

13-01-2020

Anganwadi Centres vitally Support Public Health Care System

 

The Anganwadi Centres play a crucial role in the public health care system and give pre-school education to the children, Member of Parliament Santokh Singh Chaudhary stated here on

13-01-2020

New Guidance advertised on Medical Devices and Cybersecurity


New European medical device guidance will need manufacturers to carefully review IT security and cybersecurity needs in relation to their devices and in

13-01-2020

Breakthrough Therapy Designation filed by CytoDyn with the FDA for the Utilization of Leronlimab to treat Metastatic Triple-Negative Breast Cancer


A late-stage biotechnology company known as CytoDyn Inc. is committed on developing leronlimab (PRO 140), a CCR5 antagonist with the capability for mult

13-01-2020

In Noida Free pneumonia vaccine for children is provided at government hospitals from March

 

The pneumococcal vaccine will be provided free of cost to children in the Noida from March-April this year.

The vaccine was to be introduced in Uttar Pradesh from December 1,

13-01-2020

Zero Tuberculosis’ initiative made treatment of TB simpler

 

A 24-year-old woman experiencing tuberculosis (TB) was not taking free medicines regularly due to “carelessness” of accredited social health activists (Asha) of her villa

12-01-2020

Indore district records elevation in acute severe malnutrition cases

 

Indore is going through an increase in acute severe malnutrition cases this year, as per the data of nutritional rehabilitation centre of health department. The data also indicates m

12-01-2020

6,000 yielded To Measles in DR Congo, as per WHO

 

As per the report of the World Health Organization (WHO), 6,000 people have lost their lives to a measles epidemic in the Democratic Republic of Congo (DRC).

The organization

12-01-2020

Screen of 20,000 women in Goa for breast cancer this year

 

Screening of 20,000 women living in even remote areas of Goa will be done this year for the breast cancer, as stated by health minister Vishwajit Rane on Saturday, after the inaugura

11-01-2020

Mizoram Government Condemned Over New Rules on Blood Bags Collection from Government Hospitals

 

The Mizoram government currently drew criticism from the opposition Congress over its new rule constraining the issuance of blood bags from government-run blood banks without prior p

10-01-2020

Researchers created AI system to locate and grade prostate cancer


Researchers have created a method addressed on artificial intelligence (AI) for diagnosis and grading of prostate cancer.
The AI-system has the cap

10-01-2020

URO17 bladder cancer recurrence test of KDx Diagnostics obtains USFDA breakthrough device designation


KDx Diagnostics, a company committed on developing non-invasive cancer tests to enhance early detection and therapy decisions in cancer, declared that t

10-01-2020

PMCH bid to pump up Ayushman Bharat Yojna scheme

 

Patna Medical College and Hospital (PMCH) has commenced measures to make free health cover approachable to more poor patients under the Ayushman Bharat Yojna (ABY), an aspiring&

10-01-2020

SII introduces Rotavirus Vaccine Rotasiil – Liquid; to combat Diarrhoea

 

In a work to strengthen routine immunization and manage the menace of Diarrhoea, Serum Institute of India (SII), introduced a new variant of its WHO prequalified rotavirus vacci

10-01-2020

Mizoram obtains UN assistance to fight AIDS Aizawl

 

The Mizoram govt has requested assistance from the United Nations to restrict the spread of HIV infection in the hilly state, as stated by official sources.

R Lalthangliana,

10-01-2020

Silver Bullet achieves CE Mark for antimicrobial bone screw system


Silver Bullet Therapeutics which is US-based medical device company has gained CE Mark approval for the commercial sale of its antimicrobial bone screw syste

10-01-2020

New-Born Hearing evaluation Centre Opens at Lady Goshen Hospital, Karnataka

 

A constituent unit of Manipal Academy of Higher Education (MAHE), Kasturba Medical College Mangaluru, in association with Pai Family Endowment (in memory of Shri Suhas Gopal Pai) as

10-01-2020

Reflow receives breakthrough designation for spur stent system

 

Reflow Medical has obtained breakthrough device designation for its Temporary Spur Stent System from the US Food and Drug Administration (FDA).

The retrievable stent tec

09-01-2020

TS government to bring stringent regulations to monitor private hospitals, clinics and diagnostic centres

 

The state government of Telangana is determined to bring in stringent regulations in order to monitor private hospitals, clinics and diagnostic centres in the state.

As

09-01-2020

In Punjab, 3 districts to receive early intervention centres for kids

 

The Punjab government has granted approval for setting up of 3 district-level early intervention centres for children at Patiala, Gurdaspur and Ferozepur.

The objective

08-01-2020

Abbott obtains FDA approval for procedure of heart pump implant


Abbott has gained approval from the US Food and Drug Administration (FDA) for its minimum invasive heart pump implant procedure to assist patients in av

08-01-2020

USFDA grant approval to Abbott's HeartMate 3 heart pump to aid patients avoid open heart surgery


Abbott declared that the US Food and Drug Administration (FDA) has granted approval to a new alternative surgical technique for Abbott's HeartMate 3 hea

07-01-2020

Cognetivity Neurosciences declares regulatory approval of 1st CE-marked medical device


Cognetivity Neurosciences Ltd. declared that its Integrated Cognitive Assessment (ICA) software has been granted as a CE-marked medical device. The decl

07-01-2020

FDA grants 510(k) clearance for handheld OCT scanner of PhotoniCare


510(k) clearance for PhotoniCare’s TOMi Scope has been granted by the US Food and Drug Administration (FDA) for non-invasive imaging of the middle

07-01-2020

Bioness gains CE Mark approval for StimRouter system


Bioness, a US-based medical technology company has gained CE Mark approval for its StimRouter neuromodulation system for treatment faecal incontinence.<

06-01-2020

Elevation of demand of safety syringe in India

 

As a much more extensive regulatory regime for medical devices in India takes hold, demand for safety syringes is elevating across the country. Safety-structured devices protect heal

06-01-2020

PvPI alerts physicians on rational utilization of anti-inflammatory drug nimesulide

 

In spite of being banned by the Union health ministry for utilization in patients below 12 years of age following severe adverse reaction, nimesulide is exuberantly being prescr

06-01-2020

NABH alerts healthcare organizations about fake entities obtaining empanelment for CGHS

 

The National Accreditation Board for Hospitals and Healthcare Providers (NABH) has alerted healthcare organizations about fake entities obtaining empanelment for CGHS or Ex- Servicem

06-01-2020

As per warning of NHS bosses, Supply issues with life-saving IV feed could be persistent for months

 

Hundreds of patients have been alerted of supply problems with the specially made IV feed they require to stay alive are likely to continue for months.

NH

05-01-2020

Malaria is on the reduction in WHO South-East Asia Region; efforts must be persistent as risks continues

 

As per the World Malaria Report furnished currently, in 2018 WHO South-East Asia Region had an approximated 8 million cases and 11 600 malaria deaths — 69 %and 70 % less in com

05-01-2020

Pneumonia cases elevate to 44, China to recognize cause of outbreak

 

Chinese health authorities are working to recognize what is causing an outbreak of pneumonia in the central city of Wuhan, as stated by officials on Friday, as the data of cases rose

05-01-2020

As per Ayushman Bharat FRAUD, 171 hospitals de-empanelled, Rs 4.6 crore penalty imposed

 

171 hospitals has been de-empanelled by the National Health Authority (NHA) and imposed a penalty of Rs 4.6 crore to several hospitals throughout nine states for involving in fraudul

04-01-2020

AP government rolls out updated Arogyasree Scheme covering more than 2,059 medical procedures

 

The government of Andhra Pradesh has updated the existing Arogyasree free health insurance scheme in the state and has released a new pilot project to cover 2,059 different medical p

04-01-2020

FDA of Maharashtra introduces prosecution against Trisis Ventures for non-compliance to drugs act

 

The Food and Drug Administration (FDA) of Maharashtra has introduced prosecution against Trisis Ventures in Judicial Magistrate First Class (JMFC) Court, Bhiwandi for producing disin

03-01-2020

Home minister of Delhi laid foundation for expansion of Rohini forensic lab

 

The government of Delhi is expanding the forensic science laboratory in Rohini with home minister Satyendar Jain has laid the foundation stone of an annexe building of the FSL.

03-01-2020

Study discovers dopamine, biological clock linkage to snacking, overeating and obesity

 

During the span of years, 1976 to 1980, 15 percent of U.S. adults were obese. Today, about 40 percent of adults are obese. Another 33 percent are overweight.

Colliding with t

02-01-2020

Potency of BCG may dramatically enhance if given by intravenous route

 

Tuberculosis (TB) is the major infectious cause of mortality globally, yet the world’s only licensed TB vaccine, Bacille Calmette-Guerin (BCG), was made a century ago. BCG

02-01-2020

RNTCP gets a name modification, now known as National Tuberculosis Elimination Program (NTEP)

 

With an ambition of stepping up its efforts of removing of the menace of Tuberculosis in India, the central government has announced to new nomenclature to its national TB eradicatio

02-01-2020

Recreational cannabis utilization regularly may elevate risk of cardiac abnormalities

 

People who regularly utilize cannabis are at elevated risk of adverse changes in the left ventricular size and subclinical dysfunction in comparison to people, who rarely or never co

02-01-2020

As per NEJM, Intensive LDL C lowering below 70 mg/dl lowers CV events after stroke

 

Statins have been widely utilized to lower cholesterol levels for prohibiting cardiovascular events in patients at high risk of cardiovascular disease, involving stroke. Intensive li

02-01-2020

Household insecticide utilization related to all-cause and CVD mortality as per JAMA

 

Exposure to pyrethroid insecticides for long-term is related with an elevated risk of cardiovascular death and early death, indicates a recent study appreared in JAMA Internal Medici

02-01-2020

Patients of Atopic dermatitis are at higher risk of osteoporosis

 

People suffering with atopic dermatitis (AD) are at a vitally higher risk of osteoporosis and major osteoporotic fractures, as per the recent study, absolute risk is low, but it is r

02-01-2020

FDA grants approval for Control-IQ artificial pancreas system

 

The U.S. Food and Drug Administration has granted approval for an artificial pancreas system that automatically regulates and monitors blood sugar levels.

The system is addre

02-01-2020

As per the study, Reduction of long-term risk of deep vein thrombosis by Bariatric surgery

 

Bariatric or weight loss surgery causes a vital reduction in thromboembolic events, driven by a reduction in deep vein thrombosis (DVT), as per a recent study advertised in the journ

01-01-2020

Expansion of emergency mobile service by ICMR-AIIMS initiative

 

People residing within a 5 kilometer radius of the AIIMS can now use an emergency mobile medical service in case of anyone suffering heart attack or chest pain with the authorities e

30-12-2019

MyShoulder placement guides of Medacta cleared by FDA


Medacta obtains FDA clearance for their MyShoulder Placement Guides for shoulder arthroplasty. This patient-compatibility, 3D printed solutions work in co-ex

30-12-2019

Two new cases related to polio reported in northwest Pakistan

 

2 new cases related to polio have come into light in northwest Pakistan, taking the number of those impacted by the disease in the region this year to 115.

The Emergency

29-12-2019

Exercise may lower risk for seven cancers as much as 25%

 

United States guidelines suggest three to five hours a week of moderate activity for adults or one to three hours a week of vigorous activity. A new study has associated exercising t

28-12-2019

IIT-Roorkee makes a bioresorbable, economical ortho implants for healing of bone fractures


Scholars and researchers at the Indian Institute of Technology (IIT), Roorkee have made bioresorbable and economical orthopaedic implants to heal bone fractu

28-12-2019

TS allots Rs 2 crore for installing advanced treatment facilities for eye surgeries in 19 government hospitals

 

The Telangana (TS) government has decided to update as many as 19 government hospitals across various districts with modern treatment facilities for performing free eye surgeries in

27-12-2019

Approval of Varicella Vaccine by Sinovac for Prevention of Varicella-Zoster Virus (Chickenpox) in Children

 

A leading provider of biopharmaceutical products in China, Sinovac Biotech Ltd. received China National Medical Products Administration (NMPA) grant and a Product license for th

27-12-2019

Listeria Infections Outbreak associated to Hard-boiled Eggs

 

Almark Foods prolonged its call back on December 23, 2019, to involve all hard-boiled eggs manufactured at its Gainesville, Georgia, facility due to potential exposure with List

27-12-2019

Invention of cost-effective bio-resorbable orthopaedic implants by IIT Roorkee for healing bone fractures


Invention of cost-effective bio-resorbable orthopaedic implants for healing bone fractures were done by the researchers of IIT Roorkee. The recent strat

27-12-2019

Intermittent Fasting enhances health and longevity

 

A diet of 3 meals with snacks every day is so integrated in our culture that a change in this eating pattern will rarely be considered by patients or doctors. Therefore constraining

27-12-2019

‘Screen and vaccinate policy’ is gainful and effective for dengue

 

The World Health Organization (WHO) suggests a screen and vaccinate policy for the licensed dengue vaccine (Dengvaxia, Sanofi Pasteur) so that only people with prior dengue infection

26-12-2019

Ultrasound along with MRI enhances prostate treatment


MRI-guided transurethral ultrasound ablation (TULSA) is a novel tool for the highly precise treatment of prostate cancer — without the common side

26-12-2019

First indigenous CT-scanner shipped by Siemens Healthineers from its new Bengaluru facility

 

Siemens Healthineers has shipped its 1st indigenous CT scanner from its currently launched prior art medical imaging factory in Bengaluru. The Somatom go.Now with the Somatom go

26-12-2019

MoU signed between Jivagram and Vietnam Ministry of Public Security to treat diseases through Ayurveda

 

One of the premier authentic ayurveda and panchakarma treatment of nation, Jivagram Centre for Wellbeing signed an MOU with the Traditional Medicine Hospital - Ministry of Publi

26-12-2019

For 24 hours health monitoring tiny microsensor implants has been developed


Researchers at National University of Singapore (NUS) have created tiny subcutaneous implants that can continuously quantify a heart rate, blood sugar and ot

25-12-2019

Implants specific to patients are developed at Central Scientific Instruments Organisation


Jaw and bone implants specific with patients can now be developed and created within the country, inside IARM (innovative additive research and manufact

24-12-2019

FDA clearance secured by Life Spine to market Titanium Stand-Alone ALIF Spacer System


FDA 510(K) Clearance secured by Life Spine for the Titanium Stand-Alone ALIF System. It is the 7th product of the company to obtain FDA approval this&nb

24-12-2019

De-addiction centres to be opened in all district hospitals in Haryana

 

Alerted by enhancing incidences of drug abuse in the state, the Haryana health department has made a decision to set up de-addiction centres in all district-level hospitals. Dis

24-12-2019

Shortage of Vaccine: 46% target to be obtained in 7 days

 

The aspiring vaccination of government drive against diphtheria and tetanus has come to a pause in few districts, following vaccine shortages. Karnataka needed 53 lakh TD vaccines bu

24-12-2019

As per 2013 standards Accu-Chek blood glucose monitoring systems are in compliance with latest IS/ISO 15197


Roche Diabetes Care (RDC) India declared that its Accu-Chek brand of blood glucose monitoring products are in compliance with the revised standards of I

24-12-2019

A preoperative blood test may anticipate risk of cardiac complications after surgery


The number of surgical interventions is on the elevation and together there is an enhancement in number of postoperative complications.

Of all the pa

23-12-2019

As per the ICMR study, one in seven Indians are sufferers of mental disorders

 

Approximately one in seven Indians suffered from mental disorders of ranging severity in 2017, with depression and anxiety disorders being the most general mental disorders affecting

23-12-2019

New Software System for Insulin Control was granted by FDA


Tandem Diabetes Care has secured approval in the US for a new software system that can be utilized in “artificial pancreas” systems to automatica

23-12-2019

Recalling of vagus nerve implant by LivaNova amid reset issues


LivaNova is calling back its vagus nerve stimulation (VNS) device that is implanted in patients for treatment of major depressive episodes and to control sei

22-12-2019

Prevention of ICU delirium and improvement in patient outcomes led by new developed software


Intensive care unit delirium which is a fertile area of clinical research and patient care innovation related with Vanderbilt University Medical Center,

22-12-2019

With grant of 1st trastuzumab biosimilar, WHO moves step ahead to cheaper treatment of breast cancer

 

The World Health Organization (WHO) declared Wednesday that it had for the 1 st time granted a “biosimilar” medicine — one deduced from living sources rather than c

22-12-2019

Novel genetic test may anticipate ischemic stroke at birth


Major cause of death and permanent disability worldwide is stroke. About 80% of strokes are “ischemic” — meaning, they are caused due to th

22-12-2019

Novel AI app may prohibit patients from severe falls


A novel machine learning app has been created for prohibiting patients from severe fall-related injuries and deaths. Houston Methodist have created

22-12-2019

Apollo Hospitals in Bangalore introduces first committed robot-assisted cardiac surgery unit in India

 

The cardiac surgery unit which is robot-assisted will provide patients with complex cardiac disease treatment with robotic-assisted minimally invasive cardiac surgery. The robot

22-12-2019

As per CAG, several blood banks in Uttarakhand are running for years without licenses

 

A Comptroller and Auditor General (CAG) report has become serious issue about the functioning of blood banks in Uttarakhand after observing that a number of them are running without

22-12-2019

Heavy drinking associated to adverse effect on cardiac function and structure

 

Alcohol drinking is rapidly recognized as a risk factor for cardiovascular disease (CVD). Many studies in the past have demonstrated that heavy drinking can enhance risks for al

21-12-2019

Analysis associates lifetime exposure of lead with Dementia

 

Dementia is a general problem of aged people which may be linked to risk factors such as mid- life obesity and mid-life diabetes. But aspiringly there has been a reduction in de

20-12-2019

Renewed CE mark gained by IRRAS for IRRAflow catheter

 

IRRAS received CE mark approval for its IRRAflow catheter. The new approval is gained after the company obtained 2 CE marks for its IRRAflow system’s tube set with a digital pu

20-12-2019

Recalling device by LivaNova for treatment of seizures, depression


Recalling of device by LivaNova is done which is London medical device-maker that helps in treatment of adults and children over 4 years old with partia

20-12-2019

Bristol-Myers Squibb obtains USFDA approval for CAR T cell therapy for treatment of LBCL patients

Bristol-Myers Squibb Company declared the filing of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lisocabta

20-12-2019

EB19-J10U Ultrasound Video Bronchoscope released by PENTAX in United States


PENTAX received the USFDA clearance for its new EB19-J10U endobronchial scope. The device, proposed for minimally invasive procedures such as EBUS-guide

20-12-2019

FDA down categorizes stimulators of cranial electrotherapy for insomnia, anxiety

 

FDA advertised a recommended order in January 2016 after conducting a meeting of the Neurological Devices Panel for a discussion of the CES device categorization in February 201

20-12-2019

Air pollution associated to major risk of suicide and depression

 

Air pollution by particulate has physical health effects which are well known, but linkage between exposure of particulate matter (PM) and mental illness have not yet been estab

19-12-2019

Testing Clearance in EU for FINDER Device for Bedside G6PD Deficiency


Baebies has secured the CE Mark for its FINDER device, paving the way for Europe introduction. The device can render in identifying Glucose-6- Phos

19-12-2019

AiMeD praised proposed medical devices bill by Niti Aayog to consider patient safety


Association of Indian Medical Device Industry (AiMeD) praised proposed medical devices bill by Niti Aayog to consider safety of patient and import depen

19-12-2019

FDA breakthrough nod secured for Mayo Clinic which has AI-based heart failure screening from Eko


Eko which is Digital Health Company secured breakthrough device designation from FDA for priority review of the algorithm to detect heart failure of company

19-12-2019

FDA advises Conformis over sterilization cycle failures


FDA proclaimed regarding a warning letter to Conformis, a Massachusetts-based customized joint implant manufacturer, quoting sterilization issues regarding t

19-12-2019

Breakthrough status granted to Eko’s ECG-based algorithm by FDA


Eko Devices which is a digital health firm has gained breakthrough device designation from the US Food and Drug Administration (FDA) for its ECG-based low ej

19-12-2019

Medfusion® 4000 Syringe Pumps Recalled by Smiths Medical ASD, Inc. Due to Malfunctioning Alarms and Potential Interruption of Therapy


The FDA has recognized the recall as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality

18-12-2019

FDA Clearance obtained by TAP At-Home Blood Collection System


Seventh Sense Biosystems secured FDA clearance for its TAP device to be utilized by laypersons for collection of blood.The device is now given green signal t

18-12-2019

FDA Clearance for Cranial Procedures of Medtronic Stealth Autoguide System


A cranial robotic platform from Medtronic which is the Stealth Autoguide has been given clearance by the FDA. The system renders accurate and partially autom

17-12-2019

AI-driven prostate launched by Anixa Biosciences for cancer detection test


Anixa Biosciences has commercially introduced Cchek Prostate Cancer Confirmation (Cchek PCC) test. The low-cost blood test is considered to accurately identi

17-12-2019

CE Mark obtained by Aleva Neurotherapeutics for brain stimulation system

Aleva Neurotherapeutics has obtained CE mark for its directSTIM Deep Brain Stimulation (DBS) system. The DBS system technology permits accurate steering of

17-12-2019

AI assisted polyp detector of Pentax Medical, Discovery obtains CE marking


A division of the Hoya Group, Pentax Medical received CE mark for Discovery, an innovative Artificial Intelligence (AI) assisted polyp detector structured to

17-12-2019

OmniBeds and Giraffe Incubators are recalled by GE Healthcare Recalls Due to Potential for Infants to Fall


The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality.

17-12-2019

CrossCath® Support Catheters recalled by Cook Medical Due to a production Error Which May Cause the Marker Bands to Dislodge or Cause hooking

 

The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality.

The CrossCath&re

16-12-2019

Zika blood screening test introduced by Roche


Roche has declared the launch of its cobas Zika test to markets that are in compliance with the CE mark. The cobas Zika test, which is proposed for use

16-12-2019

Tandem gains FDA clean chit for 1st interoperable, automated insulin software for dosing


FDA granted the third and final type of diabetes management technology necessary for a wholly inter-operable, automated insulin system for dosing.
The c

16-12-2019

Boston Scientific receives first US disposable duodenoscope clearance


510(k) clearance was granted by FDA to the 1st ever wholly disposable duodenoscope which is a device developed by Boston Scientific.
Jeff Shuren who is

16-12-2019

SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic


Currently, FDA released a report that Medtronic has recalled its SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, a

16-12-2019

Government to launch 4,000 AYUSH health and wellness centres

 

As stated by the Minister of State for AYUSH Shripad Yesso Naik that the Ministry of AYUSH is introducing 4,000 AYUSH healths and wellness centres this year. The ministry is loo

14-12-2019

Vaccination of 93.20 lakhs children with pneumococcal conjugate vaccine

 

Ashwini Kumar Choubey who is the Union minister of state for health stated that about 93.20 lakhs children have been vaccinated till October 2019 with pneumococcal conjugate vac

13-12-2019

FDA Approves First Disposable Duodenoscope which Reduces Risk of Infection


When duodenoscopes which are utilized for diagnosis of illness in the pancreas and bile ducts are not cleaned properly, can cause hundreds of cases of severe

13-12-2019

FDA grants tool for evaluating safety of implanted devices


An announcement was done regarding FDA securing a tool which is created to make it simpler for developers of active implantable medical devices (AIMDs) to ma

13-12-2019

SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic

Due to the potential availability of Foreign Particles Inside the Pump Motor Assembly Which May result in Pump Motor Stall Part of the SynchroMed Infusion

12-12-2019

FDA approval to Cochlear for conduction of bone implant

 

Cochlear has obtained clearance from the US Food and Drug Administration (FDA) for its Osia 2 implantable conduction hearing system of bone.
Connection between the Osia OSI200 I

12-12-2019

Strategic plan of NIH describes pathway to obtaining hepatitis B cure

 

According to the reports of US Centers for Disease Control and Prevention, an exceedingly effective vaccine to prohibit hepatitis B virus (HBV) infection has been present for nearly

12-12-2019

‘Endoscopy on wheels’ inaugurated by CM Uddhav Thackeray

 

‘Endoscopy on wheels’ which is 1st of its kind was inaurgurated by CM Uddhav Thackeray in centre at the Vidhan Bhavan premise.
Thackeray during inaugurating the faci

11-12-2019

LimaCorporate, TechMah Medical obtain USFDA 510k approval for Smart SPACE Shoulder 3D Planner & 3D Positioner

 

A global medical device company known as LimaCorporate obtains the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Being an innovative digital platform, Sm

11-12-2019

Breakthrough designation to Beta Bionics for blood sugar device

 

Breakthrough device designation status has been obtained by Beta Bionics from the US Food and Drug Administration (FDA) for its iLet Bionic Pancreas System. iLet Bionic Pancreas is a

11-12-2019

CE mark received by Roche for blood glucose monitoring app

 

CE mark has been granted to Roche for its smartphone app that permits users to quantify blood glucose level without the requirement of a meter. This is known as Accu-Chek SugarVie. T

11-12-2019

FDA labelled breakthrough device to Beta Bionics' pancreas tech


Boston-based medtech Beta Bionics received FDA Breakthrough Devices Program for its iLet system, which utilizes mathematical algorithms for dosing to automat

10-12-2019

FDA scores novel Medtronic SynchroMed II call back as Class I event


As per the reports released by agency, FDA classified a Medtronic voluntary call back of certain SynchroMed II implantable drug infusion pumps as a Class I e

09-12-2019

FDA recommends option 510(k) criteria for MRI coils

 

Issuance of a draft guidance document was done by FDA describing the performance criteria that producers of radio frequency coils for magnetic resonance imaging (MRI) can utilize to

06-12-2019

Breakthrough therapy designation received by Bristol-Myers Squibb's ORENCIA from US FDA

 

Breakthrough Therapy Designation was granted by the US Food and Drug
Administration (FDA) to Bristol-Myers Squibb Company for ORENCIA (abatacept) for the moderate to severe acut

06-12-2019

Regulatory Approval to Mainstay Medical from Australian Therapeutic Goods Administration (TGA) for ReActiv8

 

Mainstay Medical International received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation syst

06-12-2019

Cobas vivoDx MRSA of Roche Molecular System receives approval from FDA

 

Marketing approval has been granted by the US Food and Drug Administration (FDA) for cobas vivoDx, MRSA of Roche Molecular System which is a diagnostic test that helps in the detecti

06-12-2019

Tata Memorial Hospital Launches 3 new pediatric cancer units

 

With the aim of lowering patient waiting time, enhancing the rate of early detection and giving holistic care to children, Tata Memorial Hospital provides childhood cancer diagnostic

05-12-2019

FDA clearance obtained by Sight Diagnostics for Olo blood analyser

 

Sight Diagnostics  had obtained clearance from the US Food and Drug Administration (FDA) for its Olo blood analyser, which is able to process results for a complete blood test i

05-12-2019

BioPrax, Infection-Eradicating was tagged ‘Breakthrough’ by USFDA

 

“Breakthrough Device” designation has been granted to Garwood Medical Devices, LLC, from the U.S. Food and Drug Administration (FDA) for the BioPrax device of the company

05-12-2019

Surgical robot of Vicarious obtains breakthrough status by FDA


Vicarious has managed to secure breakthrough device status from FDA for Surgical's robotic surgical system. The status, is the 1st awarded to a surgical robo

05-12-2019

afib device of Boston Scientific efficient in reduction of stroke


FDA-mandated registries had 2 long-term studies which are associated to Boston Scientific's left atrial appendage closure device known as Watchman, to vital

29-11-2019

India Diabetes Care Index unveils HbA1c level enhanced in Mumbai

 

Novo Nordisk Education Foundation revealed the 1 st year report of India Diabetes Care Index under the "Impact India: 1000-Day Challenge"; programme. As per the report, HbA1c le

27-11-2019

FDA approval received by HealthLytix for prostate imaging software

 

510(k) clearance has been granted by the US Food and Drug Administration (FDA) for breakthrough prostate imaging software, RSI-MRI+ of HealthLytix.


The approval holds a

27-11-2019

System for the delivery of ear tubes approved by the FDA for local anesthesia to treat ear infection

 

An approval was granted by the USFDA to a new system for the delivery of tympanostomy tubes, commonly known as ear tubes that can be inserted into the eardrum for treatment of the re

27-11-2019

Breakthrough Therapy Designation for MDD received by Psilocybin

 

Usona Institute, Madison, Wisconsin, was recently granted with the Breakthrough Therapy designation for psilocybin by the US Food and Drug Administration (FDA) for the treatment of p

26-11-2019

Renovia obtains FDA approval for Pelvic Digital Therapeutic

 

510(k) clearance has been granted by the US Food and Drug Administration (FDA) for next- generation leva Pelvic Digital Therapeutic device of Renovia.
The therapeutic device of

26-11-2019

Novel treatment for targeting abnormality in sickle cell disease approved by FDA

 

An accelerated approval was granted by the USFDA to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. The

25-11-2019

FDA 510(k) Clearance received by US Medical Innovations for the Canady Plasma Smart XL- 1000 Generator

 

A Biomedical and Life Science subsidiary of US Patent Innovations, LLC (USPI) known as US Medical Innovations, LLC (USMI), obtained the U.S. Food and Drug Administration (FDA) 510(k)

23-11-2019

BRAC Analysis diagnostic system of Myriad Genetics received Japanese nod for breast cancer patients

 

Japan’s Ministry of Health, Labour and Welfare (MHLW) has given consent to the BRACAnalysis Diagnostic System (i.e., “BRACAnalysis”) to render physicians deter

15-11-2019

FDA approves first contact lens to slower the progression of nearsightedness in children

 

First contact lens has been approved by the U.S. Food and Drug Administration stipulated to slower the progression of myopia (nearsightedness) in children between the ages of 8

15-11-2019

FDA cleared first Duodenoscope with Sterile, Disposable Component

 

The first duodenoscope with a sterile, disposable elevator piece was cleared for marketing by the US Food and Drug Administration (FDA). The components of disposable elevator wi

02-11-2019

Stryker obtains US FDA 510(k) clearance for SAHARA lateral 3D expandable interbody system

 

Stryker, has receive the 510(k) clearance of its SAHARA Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology, from the US Food and Drug Administration (FD

01-11-2019

FDA clearance for hands-free XACT robotic system

 

Clearance for marketing has been granted by the US Food and Drug Administration (FDA) to XACT Robotics’ hands-free robotic system for usage in Computed Tomography (CT) guided p

31-10-2019

Johnson & Johnson announced expansion of tuberculosis programme in India

 

An upcoming event on Lung Health is soon going to take place in Hyderabad which is the 50th Union World Conference on the subject, led to the announcement by the John

31-10-2019

Impulse Device receives PMA approval from FDA for heart failure device

 

PMA supplement approval was received by Impulse Dynamics for its next-generation; two lead Optimizer Smart System for treatment of heart failure by the US Food and Drug Administratio

30-10-2019

Medical Device Developments: Finalization of Four 510(k) Guidance Documents by FDA


The U.S. Food and Drug Administration furnished multiple final guidance documents related to the medical device program. Here are the four guidance documents

24-10-2019

Draft Medical Devices Amendment Rules released by CDSCO for medical devices registration

 

Draft Medical Devices Amendment Rules, 2019 for registration of thirty six medical devices based on the Drugs Technical Advisory Board (DTAB) suggestions were released by the Union h

18-10-2019

All medical devices to be brought under CDSCO to improve safety & quality

 

As per the government plans, all medical devices, including implants and contraceptives are to be brought under the Central Drugs and Standard Control Organisation to ensure improvem

17-10-2019

US FDA approval to Secuado transdermal system of Noven Pharma for treating adults with schizophrenia

 

The US Food and Drug Administration (FDA) approval has been given to Secuado (asenapine) transdermal system which is the first-and-only transdermal patch formulation for the treatmen

15-10-2019

6 months transition time approval to implement provisions of new Medical Device Rules, 2017

 

A transition time of 6 months has been approved by the Union health ministry for implementing provisions of new Medical Device Rules, 2017 for the requirement of switching inventory

15-10-2019

US FDA approval to OssDsign for marketing Cranial PSI Accessories in US

 

The US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) for marketing OssDsign Cranial PSI Accessories in the US. The products which are cleared are a set of

14-10-2019

Guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses issued by CDSCO

 

Guidelines has been issued by the Central Drugs Standard Control Organisation (CDSCO) for evaluation of performance of In-Vitro Diagnostic (IVD) medical devices for grant of manufact

09-10-2019

Breakthrough Device Designation for Heart Failure to Corvia Medical's Interatrial Shunt Device (IASD®)

 

A privately-held company, Corvia Medical, Inc., which has a first-in-class structural heart device for treatment of heart failure has received the Breakthrough Device designation by

07-10-2019

NHS approval to Genedrive for baby deafness trial test

 

Genedrive a molecular diagnostics firm has obtained approval from the NHS Health Research Authority and ethics committee for the usage of the Antibiotic Induced Hearing (AIHL) test i

04-10-2019

FDA Clearance to Biofourmis Analytics Engine for Ambulatory Physiologic Monitoring

 

Biofourmis has obtained 510(K) clearance for its machine-learning and artificial intelligence (AI)-powered analytics engine as a medical device for ambulatory physiological monitorin

23-09-2019

Minimally Invasive Deformity Correction (MID-C) System - H170001 wins approval: USFDA

Minimally Invasive Deformity Correction (MID-C) System gets the USFDA approval to treat adolescent patients having idiopathic scoliosis. The intention of non-fusion spinal device known as Minimally

21-09-2019

Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Recall: Medline Industries, Inc.

An announcement has been made regarding the recalling of Medline Primary Warmer Pack and Primary Set Pack which is used to help in the administration of intravenous (IV) fluids. 

The M

13-09-2019

Health ministry partners with ECHO Trust for providing universal healthcare in India

A MoU has been signed by the Union health ministry with Extension for Community Healthcare Outcomes (ECHO) Trust, India to provide universal healthcare in India.

This collaboration is suppo

12-09-2019

FDA clearance obtained by Healthy.io for mobile-based CKD test

The test of Healthy.io can be performed at pharmacies, urgent care centres and health clinics, which eliminates the need for a tabletop lab device.

Furthermore, the test can also present im

09-09-2019

FDA breakthrough device designation to Novel system for PAH

A breakthrough device designation has been granted by the FDA to a therapeutic intravascular ultrasound system for patients with pulmonary artery hypertension.

A therapeutic ultrasound cath

05-09-2019

Anemia deficiency, NCD prevalence observed in country as per Government nutrition survey

There is prevalence of micronutrient levels, anemia, deficiency of Vitamin D, A and Iodine as per the national nutrition survey conducted by Union Government. It also states the enhancement of non-

05-09-2019

Campaign for promotion of ‘eat right movement’

The country is in dire need of a movement on preventive health for decreasing the burden of non-communicable diseases including diabetes, hypertension and heart diseases, widespread deficiencies of

05-09-2019

Moderato system wins CE Mark for treating hypertension: Orchestra

Orchestra BioMed, Biomedical company has received European CE-Mark approval for its Moderato implantable pulse generator system to treat patients with hypertension.

Moderato functions with

02-09-2019

FDA granted breakthrough device designation to MagicTouch AVF sirolimus-coated balloon

FDA granted the breakthrough device designation for MagicTouch AVF, its sirolimus drug-coated balloon (DCB) catheter used for treating the stenotic lesions of arteriovenous fistulae or arteriovenou

31-08-2019

US FDA breakthrough device status to Conceptualize Medical's Sirolimus DCB catheter, MagicTouch AVF

Concept Medical Inc. (CMI) wins US Food and Drug Administration (FDA) grant as “Breakthrough Device Designation” for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, fo

31-08-2019

10 Ayush health and wellness centres were rolled out by Haryana government

10 Ayush health and wellness centres (Ayush HWCs) were rolled out by Haryana government. This is in relation with Union Ayush Ministry mandate to set up 12,500 Ayush HWCs in the country in upcoming

28-08-2019

FDA approval to ApiFix MID-C system to treat adolescent idiopathic scoliosis

The US FDA has approved ApiFix for the commercialization of Minimally Invasive Deformity Correction (MID-C) system. This approval has been done through Humanitarian Device exemption for the treatme

22-08-2019

SAPIEN 3 Ultra Delivery System Recall by Edwards Lifesciences, LLC

The SAPIEN 3 Ultra delivery system of Edwards is being recalled by the organization. It is required for delivering and deploying the Edwards SAPIEN 3 Ultra transcatheter heart valve or the Edwards

21-08-2019

Centurion Medical Products' Primary Warmer Pack by Medline Industries, Inc. Recalled

An announcement has been made regarding the recalling of Medline Primary Warmer Pack, which is used to help in the administering of intravenous (IV) fluids. The Medline Primary Warmer Pack constitu

21-08-2019

MED-EL Cochlear Implant System - P000025/S104 wins USFDA approval

The MED-EL Cochlear Implant System gets the USFDA approval to produce auditory sensations. The intention of MED-EL Cochlear Implant System is to produce auditory sensations by giving electric stimu

20-08-2019

PD-L1 IHC 22C3 pharmDx - P150013/S016 wins USFDA approval

The lab test used by doctors for checking the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients, who have esophageal squamous cell cancer is done by PD-L1 IHC 22

19-08-2019

Medical device manufacturer can now ask for FDA feedback after inspection

The FDA has notified in a draft that in coming times, they will offer nonbinding feedback after completion of their inspection at medical device manufacturer.

The FDA explained the complete

18-08-2019

First spinal tether device wins the USFDA approval for treating idiopathic scoliosis

The US FDA has given the approval to first spinal tether device to be used in adolescents and children having idiopathic scoliosis. It is an alternative to surgical treatment.

The Zimmer Bi

16-08-2019

The Tether™ - Vertebral Body Tethering System - H190005 grabs USFDA approval

The USFDA approval is granted to the Tether-Vertebral Body Tethering system. The intention of non-fusion spinal device known as Tether™ - Vertebral Body Tethering System is to treat idiopathi

16-08-2019

Medtronic CoreValve System; Medtronic CoreValve Evolut R System; Medtronic CoreValve Evolut PRO System - P130021/S033 gets approval from USFDA

The USFDA gives the approval to CoreValue system developed by Medtronic. Three design iterations are present in the Medtronic CoreValve family of devices: the Medtronic CoreValve System (1st genera

16-08-2019

USFDA approves Edwards SAPIEN 3 Transcatheter Heart Valve System - P140031/S085

The SAPIEN 3 Transcatheter Heart Valve (THV) System and Edwards SAPIEN 3 Ultra THV System of Edward, both consist of an artificial catheter-based aortic heart valve and accessories used for implant

16-08-2019

BAROSTIM NEO System - P180050 wins USFDA approval

Barostim NEO system gets the USFDA approval to treat advanced heart failure. An implantable pulse generator (IPG), a carotid sinus lead kit and a programmer are included in the BAROSTIM NEO System.

15-08-2019

FDA Breakthrough designation to V-Wave's Interatrial Shunt regarding Device Designation for Heart Failure

A privately held medical device company known as V-Wave Ltd., developing new implantable interatrial shunt devices receives the Breakthrough Device Designation from the U.S. Food and Drug Administr

12-08-2019

Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Recall: Fresenius Kabi

Fresenius Kabi announced the recall of Volumat MC Agilia Infusion System which is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood pro

09-08-2019

NvisionVLE Imaging System wins FDA clearance

 

NvisionVLE Imaging System can now be marketed by NinePoint Medical following clearance from the US FDA. It can give high-resolution volumetric images of the subsurface and surfa

09-08-2019

CE marking to Meril Life Sciences for bioresorbable scaffold stent

Meril Life Sciences receives CE marking for their scaffold -MeRes100 BRS, becoming the first thin-strut bioresorbable scaffold. 

Cardiovascular related diseases such as coronary artery

09-08-2019

USFDA approves Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System - P130021/S058

Both of the sytems, the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO gets the USFDA approval. Both consists of a transcatheter aortic valve (TAV), a delivery catheter, and

07-08-2019

CE Mark approval wins by ExThera for Seraph 100

Seraph 100 by ExThera Medical, developed for pathogen reduction during bloodstream infection gets the CE Mark approval. Obtaining the CE mark approval confirms the safety of Seraph 100.

&nb

05-08-2019

Abbott recalls Ellipse Implantable Cardioverter Defibrillators

Implantable cardioverter defibrillators with model numbers CD1377-36C, CD1377-36QC, CD1411-36Q, CD2377-36QC, CD2411-36C, CD2411-36Q manufactured between 05 April 2019 till 29 May 2019 are bein

05-08-2019

OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te

05-08-2019

OncoBEAM RAS CRC kit gets Japanese approval

Sysmex Corporation achieves the Japanese approval to manufacture and market OncoBEAM RAS CRC Kit. It is used in the patients of colorectal cancer for blood-based circulating tumour DNA molecular te

02-08-2019

Medical device manufacturing sites will be audited by 6 bodies: CDSCO

According to the new MD Rules, the 6 bodies are notified by the CDSCO to audit the medical device manufacturing sites.

The new MD Rules 2017 became effective since 01 January 2018. These ru

02-08-2019

Filter Tips by QIAGEN recalled due to inaccurate or delayed results

1500 µl filter tips to be used with QIAGEN QIAsymphony SP/AS instruments, model number REF 997024 with lot number 0605020019 and 0605020020 are recalled due to delayed or incorrect results.

02-08-2019

FDA Draft guidance on Medical Device’s Safety in MRI Environment

A new draft guidance namely Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment has been issued by the U.S. Food and Drug Administration (FDA).

Unique

02-08-2019

Public health emergency declared by Florida’s surgeon general

A public health emergency was declared by the Florida Surgeon General Dr. Scott Rivkees to encounter the rise in Hepatitis A cases in Florida because of the ongoing national outbreak.

This

02-08-2019

USFDA: Green signal to PD-L1 IHC 22C3 pharmDx - P150013/S014

The USFDA grants green signal to PD-L1 IHC 22C3 pharmDX. The lab test used by doctors for checking head and neck squamous cell cancer having programmed cell death ligand 1 (PD-L1) in their cancer i

01-08-2019

Welch Allyn RetinaVue 700 Imager Launched by Hillrom

Hillrom launches the Welch Allyn RetinaVue 700 Imager, a retinal camera to detect diabetic retinopathy. It is a recent innovative diagnostic technology.

It helps distant ophthalmologists to

01-08-2019

Delivering accurate chest compression now becomes easy
The researchers from University of Applied Sciences and Fraunhofer Institute for Silicate Research have developed a device, named Rescue Aid. It assists in administering the ch

01-08-2019

Improvement in Powered Prosthetic Arms by Implanted Electrodes

In recent times, few built-in electrodes are present in conventional powered prosthetic arms that make connection with skin of the patient. These are good enough to open and close a simple claw, bu

01-08-2019

ECG, Breathing, Heart Rate measurement continuously for weeks using Flexible Body Monitor

Long-term continuous monitoring of physiological activity can impart precise information about an individual’s health. Children, elderly, and people with varied conditions often face difficul

01-08-2019

Rescue Aid to deliver accurate chest compressions

It is well known that perfectly delivered chest compressions can save an individual from cardiac arrest. However, this is not an easy task for the bystanders to perform the resuscitation because in

31-07-2019

Quality requirement draft on combination products: EMA

A draft guideline is published by the European Medicines Agency (MEA) on quality requirements for medical devices and medicinal products combination. This combination is also known as Drug device c

31-07-2019

Medical device’s encryption standards ‘needs to be compulsory’

An internet of things (IoT) company has warned that it is necessary to legally enforce the encryption standards on the medical devices. Encryption is mandatory for both developers and users. This i

31-07-2019

Johnson and Johnson’s faulty hip implants issue raised in Rajya Sabha

Anand Sharma, congress leader, requested the current government to make the regulatory norms more stringent so that the incident like Johnson & Johnson’s selling faulty hip implants shoul

30-07-2019

EMA suggests women to avoid Gilenya medicine during pregnancy

The EMA (European Medicines Agency) has alerted the pregnant women and the women able to have children, who are not using effective contraceptives against the use of multiple sclerosis medicine Gil

30-07-2019

Aortix system of Procyrion received Breakthrough Device Designation from FDA

The Aortix system of Procyrion Inc. has secured the Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). It is a percutaneous circulatory support system for medical-con

29-07-2019

Diaphragmatic pacing programme to be introduced by ISIC in India

Indian Spinal Injuries Centre(ISIC), leading facility in spinal injury treatment, has tied up with Dr Raymond P Onders, American Gastrointestinal Surgeon, to introduce a diaphragmatic pacing progra

28-07-2019

MoU signed between National Health Authority and NATHEALTH

National Health Authority (NHA) and NATHEALTH- Healthcare Federation of India has signed a Memorandum of Understanding (MoU) to bring new innovations in the healthcare sector. These innovations wil

27-07-2019

Free testing, treatment for Hepatitis B and C announced by Government of India

As part of the Universal health coverage plan, Indian government is offering free testing and treatment for Hepatitis B and C. This offer comes on World Hepatitis Day, Dated July 28.

In Ind

27-07-2019

Rotavirus vaccination launched by Goa Health Minister

Vishwajit Rane, Health Minister of Goa, launched the rotavirus vaccination programme in the state. He started the programme by administering the vaccine to a child.

Free of cost 2.5 ml vacc

27-07-2019

Medtronic’s VenaSeal Closure System unveiled in India treat CVD patients

Medtronic Private Limited has launched its VenaSeal Closure System in India to treat the people suffering from chronic venous disease (CVD). It is an invasive procedure in which the diseased vein i

26-07-2019

MDTAG constituted by Health ministry

A Medical Devices Technical Advisory Group (MDTAG) has been constituted by the Union Health Ministry. The group will be giving advice to the Central Drugs Standard Control Organization (CDSCO) on m

25-07-2019

Bausch and Lomb’s faulty adrenaline auto-injector gets Regulatory warning

The UK MHRA has announced in the alert letter that about 0.23% syringe pens (2.3 pens in every 1,000) manufactured by Bausch & Lomb fails to deliver adrenaline’s dose due to needle blocka

24-07-2019

Microfluidics device developed for sepsis diagnosis

An automated, microfluidics device has been developed by the researchers from Massachusetts Institute of Technology (MIT) in the US. It will help in the detection of sepsis with 25 minutes.

23-07-2019

Medical Device Cybersecurity Recommendations drafted by France

The draft recommendations on the cybersecurity of medical devices have been developed by France’s National Agency for the Safety of Medicines and Health Products (ANSM).

These recomme

23-07-2019

All Intra-Aortic Balloon Pump models recalled by Maquet

The FDA has recognized the recall of Maquet/Datascope Intra-Aortic Balloon Pumps (IABP), models Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i, as the Class Ⅰ recall.

IABP, a

23-07-2019

Medtronic to make Viz.ai’s AI stroke detection software

Medtronic, an Irish medical technology firm, has decided to make the artificial intelligence (AI)-based stroke care solutions provider Viz.ai’s new technology available to different centers i

23-07-2019

First cochlear device for single-sided deafness approved by FDA

Med-El North America, a Durham, N.C.-based firm has received an approval from the FDA for its cochlear implant system. This new device is first of its kind that can be used in people with single-si

17-07-2019

20 million children missed out on life saving Measles, Diphtheria and Tetanus vaccines

According to the WHO, during 2018 around 20 million children worldwide were missed out on life-saving vaccines including diphtheria, measles and tetanus. Mostly, the poorest and most marg

16-07-2019

Digital Inhaler approved for Asthma patients: FDA

AirDuo Digihaler (fluticasone propionate 113mcg and salmeterol 14mcg), an inhalation powder, has been approved by the FDA. It is meant for asthma treatment in patients aged 12 years and older, but