Healthcare Newsletter

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