03-03-2021 World Report on Hearing depicts 1 in 4 people projected to have hearing problems by 2050: WHO
Approximately 2.5 billion people worldwide - or 1 in 4 people - will live with some minor hearing loss by 2050 and warns the World Health Organization’s (WHO) first World Repor |
03-03-2021 Launch of multilingual pediatric vaccine awareness campaign on Public App: GSK Pharma
GlaxoSmithKline Pharma launched a massive public interest campaign called "Health ka Passport" on Public App across all major Indian languages. The ad campaign seeks to educate child |
03-03-2021 Positive results from Inovio's REVEAL 1 trial of VGX-3100 to treat high-grade precancerous cervical dysplasia caused by HPV-16/18
Inovio declared that positive results from REVEAL 1 trial. This trial is one |
02-03-2021 US FDA Emergency Use Authorization to Eurofins EmpowerDX Covid-19 Home Collection Kit
Eurofins’s Clinical Enterprise announced the grant of US FDA Emergency Use Authorization (EUA) for its EmpowerDX Covid-19 Home Collection Kit, a direct-to-consumer (DTC) versio |
02-03-2021 US FDA Emergency Use Authorization to Eurofins EmpowerDX Covid-19 Home Collection Kit
Eurofins’s Clinical Enterprise announced the grant of US FDA Emergency Use Authorization (EUA) for its EmpowerDX Covid-19 Home Collection Kit, a direct-to-consumer (DTC) versio |
01-03-2021 Single-shot Covid-19 vaccine obtains US CDC panel recommendation: Johnson & Johnson
Johnson & Johnson declared that the US Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first& |
01-03-2021 Results announced from phase 2 OSCAR study evaluating otilimab for treating hospitalized Covid patients: GSKGlaxoSmithKline plc (GSK) declared results from the proof of concept OSCAR (Otilimab in Severe Covid-19 Related Disease) phase 2 study with otilimab. The primary endpoint wa |
01-03-2021 Amgen and AstraZeneca announce successful phase 3 results of tezepelumab; to widen treatment options for severe asthma
AstraZeneca Plc and Amgen Inc jointly announced the phase 3 clinical trial results of the biologic tezepelumab in severe and uncontrolled asthma patients. It demonstrated a clinicall |
01-03-2021 Launch of FDR Nano, digital radiology system: Fujifilm India
Fujifilm India Private Limited declared the launch of its mobile digital radiology system – FDR Nano. This new digital radiology technology with high-resolution imaging with lo |
01-03-2021 Launch of FDR Nano, digital radiology system: Fujifilm India
Fujifilm India Private Limited declared the launch of its mobile digital radiology system – FDR Nano. This new digital radiology technology with high-resolution imaging with lo |
27-02-2021 Launch of campaign to raise awareness on depression and other mental health issues: United We Care
United We Care, a web and app-based platform for emotional well-being, recently launched a campaign to increase awareness on depression and other mental health issues. It ask |
27-02-2021 Reduced transmission after one dose of Pfizer's Covid-19 vaccine: UK study
Pfizer and BioNtech's Covid-19 vaccine's single-dose reduces the number of asymptomatic infections. It could significantly reduce the risk of transmission of the virus depicted from |
27-02-2021 Qiagen and INOVIO expand partnership into developing liquid biopsy diagnosis on NGS technology to treat cervical dysplasia
Qiagen, a Netherlands-based holding company, and INOVIO Pharmaceuticals, a biotechnology company, declared an extension of their collaboration with a new master partnering agreement |
27-02-2021 US FDA approves nasopharyngeal specimen collection swabs RT-PCR test kit: MJ Biotech's
MJ Biotech declared US Food and Drug Administration (FDA) approval of Sterile and individually wrapped nasopharyngeal (NP) specimen collection swabs for the RT-PCR Covid test. This C |
26-02-2021 CityHealth brings a novel home-based Covid-19 testing kit.CityHealth Urgent Care, a healthcare clinic in the US, has come up with a new home-based test kit for Covid-19 patients. The In-Home COVID-19 Test Kit contains a how-to guide, a sterile swa |
25-02-2021 BioIQ collaborates with Assurance Scientific for in-home Covid-19 test kits.BioIQ and Assurance Scientific Laboratories have partnered to bring over-the-counter (OTC) RT-PCR Covid-19 testing kits in the market. They have received the US Food and Drug Administration |
25-02-2021 Medtronic issued a global recall of unused Valiant Navion thoracic stent graft systems
A safety issue has induced Medtronic to issue a global recall of unused Valiant Navion thoracic stent graft systems during a worldwide clinical trial. For the sake of patient safety, |
24-02-2021 FDA stops Hand Sanitizers with very low Alcohol Content at the U.S. Border
The U.S. Food and Drug Administration is closely observing the content of hand sanitizer products imported into the United States. Of late, a product calle |
29-01-2021 Launch of #YesICan campaign to create awareness on leprosy: Sasakawa-India Leprosy Foundation
Sasakawa-India Leprosy Foundation (S-ILF) launched the #YesICan campaign to generate awareness amongst the folks on the eve of Anti-leprosy Day. The campaign intended to create aware |
28-01-2021 AstraZeneca vaccine shouldn't be given to over-65s, citing lack of data
Germany's vaccine commission said the AstraZeneca coronavirus should not be given to people aged over 65 years, amid a sour dispute between the European Union and the drugmaker over |
28-01-2021 Positive results of VIR-3434 in patients with chronic hepatitis B virus from phase 1 trial: Vir Biotechnology
Vir Biotechnology declared initial topline data from its ongoing trial of VIR-3434 with chronic hepatitis B virus (HBV) infected patients. VIR-3434 is an HBV-neutralizi |
28-01-2021 Positive results from once-daily relugolix combo therapy in women with endometriosis: Myovant and Pfizer phase 3 SPIRIT extension study
Myovant Sciences and Pfizer declared that relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg (the investigational once-daily relugolix combination therapy) in end |
28-01-2021 Symbicort Turbuhaler receives China NMPA approval as an anti-inflammatory reliever in mild asthma: AstraZeneca
AstraZeneca declared that its Symbicort Turbuhaler (budesonide/formoterol 160/4.5mcg) is approved in China as an anti-inflammatory reliever to be used as needed in response to sympto |
28-01-2021 Panbio Covid-19 Ag rapid test device granted CE Mark for asymptomatic screening and self-administered sample collection with nasal swab: Abbott
Abbott declared that it had rec |
27-01-2021 Renewed partnership to deliver hematology testing solutions: Roche and Sysmex
Roche declared that it entered into a Global Business Partnership Agreement (GBP) with Sysmex. Under this, the parties renewed their commitment to the extended-standing distribution, |
27-01-2021 ADLINK Technology introduces a new range of surgical monitors
ADLINK Technology launched the ASM (ADLINK Surgical Monitor) series of surgical monitors developed for integration with microscopic, fluoroscopic, endoscopic, multi-mo |
27-01-2021 Calquence’s ELEVATE-RR phase III trial meets primary endpoint to treat CLL: AstraZeneca
AstraZeneca declared positive high-level results from the ELEVATE-RR phase III trial of Calquence (acalabrutinib). The study met the primary endpoint showing non-inferior PFS (progre |
27-01-2021 Faricimab’s Phase III TENAYA & LUCERNE studies to treat nAMD (neovascular or wet age-related macular degeneration) meet primary endpoint: Roche
Roche declared positive results from TENAYA and LUCERNE (two identically designed global phase III studies), analyzing its investigational bispecific antibody, faricimab, in people w |
26-01-2021 Launch of "Game-changing," 24/7 automated Blood Pressure monitoring system
Aktiia announced a 24/7 automated blood pressure monitoring system in the UK after receiving CE Mark as a Class IIa medical device. It can record blood pressure data throughout the d |
26-01-2021 Positive results from Carragelose lozenges against respiratory viruses of SARS-CoV-2: Marinomed
Marinomed Biotech AG declared positive results from its clinical study on the antiviral efficacy of Carragelose-containing lozenges (10 mg iota-carrageenan) in 31 healthy subjects. R |
26-01-2021 Positive results from part 1 of pivotal FIREFISH study Evrysdi in infants with Type 1 spinal muscular atrophy: Roche
Roche declared that the New England Journal of Medicine had published data from the dose-finding Part 1 of the pivotal FIREFISH study of Evrysdi (risdiplam) in infants with symptomat |
26-01-2021 Chondro3 receives US FDA breakthrough device designation: Locate BioLocate Bio declared that the US Food and Drug Administration granted Breakthrough Device designation to Chondro3 - a biomimetic graft for osteochondral lesions. Chondro3 is currently in development |
25-01-2021 Scientists demand stern control measures to mitigate the spread of new COVID-19 variants
A group of scientists having expertise in evolution, virology, infectious disease, and genomics from the University of East Anglia (UEA), Earlham Institute, and University of Minneso |
25-01-2021 Experts conduct a review of deaths reported in Europe after BNT162b2 vaccination
The virtual meeting of the GACVS COVID-19 Vaccine Safety subcommittee held on January 19, 2021, to evaluate the information and data available on deaths reported in frail, elderly in |
25-01-2021 Opening of Jan Aushadhi outlets in all PHCs: AP govt plans
The Andhra Pradesh (AP) government is aggressively working to open the PMBJK (Pradhan Mantri Bhartiya Janaushadhi Kendras) outlets or Jan Aushadhi Stores in all the public health cen |
25-01-2021 Methamphetamine overdose deaths rise acutely among American Indians & Alaska Natives: Finding from NIH-supported study
Methamphetamine overdose deaths surged in eight years in the United States, according to a study that will be published in JAMA Psychiatry. The analysis revealed a rapid increase acr |
25-01-2021 Launch of Assay to detect a patient's COVID-19 antibody levels
Beckman Coulter, a clinical diagnostics firm, launched its Access SARS-CoV-2 IgG II assay in the CE mark accepting countries. The new assay quantitatively measures a patient's antibo |
24-01-2021 Second-generation "double antibody" offers protection from SARS-CoV-2 and its tested variants
The Institute for Research in Biomedicine (Switzerland), affiliated to the Università Della Svizzera Italiana (USI), has come up with a second-generation 'double-antibody' tha |
23-01-2021 Elecsys Anti-SARS-CoV-2 S test against SARS-CoV-2: Roche Diagnostics
Roche Diagnostics India declared the launch of its antibody test SARS-CoV-2 test - Elecsys Anti-SARS-CoV-2 S. The test is CE IVD approved and has received ICMR and CDSCO appr |
23-01-2021 OraSure’sOrageneDx saliva collection kit included in industry’s first US FDA authorization for whole-exome sequencing platform
OraSure Technologies declared that its OrageneDx (OGD-610) saliva collection device was incorporated as a component in the De Novo authorization granted by the US FDA for a whole-exo |
23-01-2021 Bamlanivimab's Phase 3 BLAZE-2 trial reduces the risk of contracting symptomatic Covid-19 up to 80% for residents: Lilly
Eli Lilly and Company declared that bamlanivimab (LY-CoV555) significantly decreased the risk of contracting symptomatic Covid-19 in long-term care facilities staff and residents. |
23-01-2021 USFDA new norms for ANDAs to ensure patient safety & data integrity in BE studies, during this pandemic
Indian clinical trial sector welcomes US FDA new norms to protect participants in BE studies for ANDAs (abbreviated new drug applications) to ensure patient safety and data integrity |
22-01-2021 Boston Scientific's Vercise Genus deep brain stimulation system receives FDA approval
The FDA approved Boston Scientific's Vercise Genus deep brain stimulation (DBS) system portfolio for conditional use in a magnetic resonance imaging (MRI) environment. It comprises o |
22-01-2021 Association between impaired metabolic health, obesity, and COVID-19 severity
The authors from the German Center for Diabetes Research (DZD) spotlight the link between obesity and impaired metabolic health with the COVID-19 severity in a Nature Review |
21-01-2021 Lightpoint Medical receives CE mark approval for its Robotic gamma probe for intra-operative cancer detection
Medical device company Lightpoint Medical's Robotic gamma probe for intra-operative cancer detection received CE mark approval. The miniaturized surgical tool named SENSEI is designe |
21-01-2021 Bharat Biotech issues fact sheet for Covaxin
Bharat Biotech has officially released a fact sheet for its Covaxin Covid-19 vaccine, indicating that the vaccine is contraindicated in people who have allergies, fever or bleeding d |
20-01-2021 VaxArray Measles & Rubella antigen quantification kit: InDevR
InDevR, a life science tools company, announced its VaxArray Measles and Rubella (MR) antigen quantification kit's commercial availability. The Bill and Melinda Gates Foundat |
20-01-2021 MHRA approves CoverScan MD, Imaging service for Long-COVID-19
The (MHRA) Medicines & Healthcare products Regulatory Agency of UK approved Perspectum's CoverScan MD, an MRI-based technology to map the effects of COVID-19 on several of the bo |
20-01-2021 Positive results of Fotivda in combo with Imfinzi from phase portion of DEDUCTIVE trial to treat patients with advanced or metastatic HCC: AVEO Oncology
AVEO Oncology declared the presentation of results of Fotivda (tivozanib), in combination with AstraZeneca’s human monoclonal antibody directed against programmed death-ligand |
19-01-2021 Positive phase 1 results of high-dose setanaxib in primary biliary cholangitis patients: Genkyotex
A Calliditas Therapeutics AB's (publ) subsidiary, Genkyotex SA, declared positive phase 1 data with a commendatory pharmacokinetic and safety profile of high-dose setanaxib. |
18-01-2021 MLC-AL & MLC-KL(medical panel computers): ADLINK Technology
ADLINK Technology Inc. has launched the MLC-AL and MLC-KL series of medical panel computers specifically developed for integrated system control and complex medical data management. |
18-01-2021 Researchers discover a nutrient that can help in the prevention of bacterial infection
Scientists at the National Institutes of Health (NIH), USA, are conducting and supporting basic, clinical, and translational medical research to investigate the causes, treatments, a |
18-01-2021 Phase 2 FIGHT trial assessing bemarituzumab in advanced gastric/GEJ cancer meets all three efficacy endpoints: Five Prime Therapeutics
Five Prime Therapeutics, Inc., declared clinical results from the global, double-blind placebo-controlled, randomized, phase 2 FIGHT trial analyzing first-in-class targeted therapy b |
18-01-2021 SCTIMST enters technology transfer agreement with Biorad Medisys for intracranial flow diverter stent
SCTIMST signed technology transfer agreements with the Pune-based Biorad Medisys for two biomedical implants, an intracranial flow diverter stent and an atrial septal defect occ |
18-01-2021 ICMR allows Neuberg to conduct COVID-19 tests in Noida, Salem, Vizag, and Kozhikode
The Indian Council of Medical Research (ICMR) granted Neuberg Diagnostics approval to conduct Covid-19 tests in Noida, Vizag, Salem, and Kozhikode. Neuberg Diagnostics is the fourth |
18-01-2021 MyHealthcare and AliveCor join hands for home-based ECG monitor, KardiaMobile 6L
MyHealthcare and AliveCor announced their partnership for their KardiaMobile 6L device that allows patients to read their ECG data at home. The collaboration brings an integrated car |
16-01-2021 PerkinElmer's Coronavirus Nucleic Acid Detection Kit: US FDA emergency use authorization
PerkinElmer declared that its New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization (EUA) from the US FDA to test individuals without symptoms or other reas |
16-01-2021 Merck and Philips partnership to develop clinical-grade digital solutions for personalized fertility treatment
Royal Philips declared a multi-year partnership with Merck to develop clinical-grade digital solutions for highly customized fertility treatment. These solutions aim to better inform |
15-01-2021 Launch of digital health app: Abbott
Abbott's neuromodulation portfolio is around Proclaim XR, a version of a St. Jude Medical spinal cord stimulation (SCS) device approved by the FDA in 2015, and the Proclaim DRG Syste |
15-01-2021 Market release of SCS systems: Boston Scientific
Boston Scientific has enlarged its SCS portfolio with the limited market release of its WaveWriter Alpha SCS (Spinal Cord Stimulator) Systems. The port |
13-01-2021 Rehabilitation tech tie-up: maxon and Fourier Intelligence
maxon Group and Fourier Intelligence declared about entering into a global strategic partnership to develop rehabilitation technologies. Technology |
11-01-2021 COVID-19 false-negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests: Flagged FDA
The FDA alarmed healthcare providers and clinical laboratory staff regarding the U.K. coronavirus variant and other emerging forms of the virus' impact on specific PCR test results.< |
06-01-2021 Pfizer-BioNTech vaccine approved for emergency use: Colombia regulator
Colombia’s food and drug regulator recently authorized the emergency use of Pfizer Inc and BioNTech SE’s COVID-19 vaccine. The National Institute of Food and Drug |
06-01-2021 Grants 510(k) clearance to Accuray'sClearRT Helical kVCTImaging for Radixact treatment delivery system: US FDA
Accuray Incorporated declared about grant of 510(k) clearance from the US Food and Drug Administration (FDA) for its ClearRT Helical kVCTImaging for the Radixact System, the latest T |
04-01-2021 Nod to Bharat Biotech & SII vaccine candidates for restricted emergency use in India for management of COVID-19: CDSCO
The Central Drugs Standard Control Organisation (CDSCO) has approved Serum Institute of India (SII) and Bharat Biotech vaccines named Covishield and Covaxinfor, respectively, for res |
04-01-2021 Positive results with opaganib in patients hospitalized with COVID-19 pneumonia: RedHill Biopharma's phase 2 study
RedHill Biopharma Ltd. declared the preliminary positive data with orally-administered opaganib (Yeliva, ABC294640) in patients hospitalized with COVID-19 pneumonia. The US phase 2 s |
02-01-2021 Seeks marketing approval for COVI-STIX rapid detection test of SARS-CoV-2 viral antigen: Sorrento Therapeutics San Diego
Sorrento Therapeutics declared that its agents in Mexico had submitted a Marketing Authorization Application to Mexico's health regulatory authority for its COVI-STIX rapid diagnosti |
02-01-2021 Micro-Tech Endoscopy and Interscope ink partnership to distribute EndoRotor System for interventional gastroenterology
Micro-Tech Endoscopy and Interscope Inc signed a partnership agreement to collaborate and distribute the EndoRotor System for interventional gastroenterology. It is a s |
02-01-2021 Issuance of emergency use validation for Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty: WHO
The WHO declared the Comirnaty vaccine for emergency use, resulting in the Pfizer/BioNTech vaccine to be the pioneer to get emergency validation from WHO since the outbreak began a y |
29-12-2020 Fitgo launches a range of infrared thermometers with the latest technology
Fitgo has come up with a range of infrared thermometers with the latest technology that may be launched worldwide. The new devices have advanced sensor technology that gives results |
23-12-2020 Medtronic launches The Tri-Staple EEA™ Circular Stapler In India
Medtronic India launched EEA™ Circular Stapler with Tri-Staple™ Technology. It is touted as the first 3-row Circular Stapler with varied height staples causing lesser str |
22-12-2020 Phase 3 LACEWING trial of Xospata plus azacitidine fails to meet primary endpoints to treat acute myeloid leukemia: Astellas Pharma.
Astellas Pharma declared that a phase 3 trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) AML (acute myel |
22-12-2020 Phase 3 YOSEMITE and RHINE trials of faricimab meets primary endpoints to treat diabetic macular edema (DME): Roche
Roche declared positive results from two identically designed-YOSEMITE and RHINE, randomized, multicentre, double-masked, global phase III studies, evaluating its investigational bis |
22-12-2020 Health Canada approves Micra AV pacemaker from Medtronic
Health Canada granted its approval to Medtronic Canada's Micra AV pacemaker with atrioventricular synchrony. The USFDA approved the device in January 2020. The leadless |
22-12-2020 Rapid Medical’s steerable neurovascular guidewire gets FDA clearance
The USFDA granted clearance to Rapid Medical’s Drivewire; the guidewire used to treat vascular diseases. The Israel-based company aims to help treating doctors control |
22-12-2020 The error rate of pulse oximeters reportedly increases in Black patients
According to a study shared with the New England Journal of Medicine, pulse oximeters have a higher error rate with Black patients. The study states that the handy devices may give m |
22-12-2020 FDA grants EUA to Quidel's instrument-free COVID-19 antigen test
Quidel's instrument-free COVID-19 antigen test received FDA's emergency use authorization (EUA). It is a pregnancy test-style product that can deliver results in minutes. Qui |
17-12-2020 Implant meant to fix ACL tears gets FDA De Novo
FDA has approved a resorbable implant under the De Novo premarket review pathway that can fill the crack between the torn ends of a person's anterior cruciate ligament (ACL). It is o |
17-12-2020 Penumbra recalls catheter device: FDA's request
The catheter device, Jet 7 Xtra Flex, of Penumbra is recalled because of the injury risk and even death during removing clots in stroke patients, after FDA advice. The company announ |
12-12-2020 Launch of Elecsys SARS-CoV-2 antigen test to detect COVID-19: Roche
Roche declared the launch of the high-throughput SARS-CoV-2 antigen test to aid in diagnosing SARS-CoV-2 infections (Severe Acute Respiratory Syndrome Coronavirus 2) with the CE Mark |
10-12-2020 Co-WIN mobile app for COVID-19 vaccine delivery
The Central government has launched a new digital platform called Co-WIN for COVID-19 vaccine delivery. There will be a new mobile app and will allow people vaccine registration. |
10-12-2020 HealthiumMedtech launches Surestitch, a meniscal repair device
HealthiumMedtech has come up with the first 'Made in India' meniscal repair device. The device named 'Surestitch' is a part of its arthroscopy range Sironix. The company has applied |
09-12-2020 Updated guidance issued on systematic screening of tuberculosis (TB) disease: WHO
In a Rapid Communication issued, the World Health Organization (WHO) declared several updates to its prospective guidance on TB disease's systematic screening. The updated guidance w |
09-12-2020 Carpediem cardio-renal pediatric dialysis emergency machine: Medtronic, US
Medtronic plc declared the commercial launch of the Carpediem cardio-renal pediatric dialysis emergency device. After the US FDA marketing authorization grant earlier this year, the |
08-12-2020 CE mark approval to Advaite’s RapCov rapid antibody test for COVID-19
Advaite, an innovative biotechnology company, declared that it had obtained CE Mark approval for its rapid IgG antibody test called RapCov, which will help contain the spread of coro |
08-12-2020 Launch of QuantiFERON SARS-CoV-2 RUO solution to detect T-cell response: QIAGEN
QIAGEN declared the launch of its QuantiFERON SARS-CoV-2 Research Use Only (RUO) solution to detect T-cell responses of the immune system to the COVID-19 causing pathogen in humans, |
08-12-2020 Positive results of Yescarta to treat large B-cell lymphoma phase 2 ZUMA-12 study: Kite
Kite declared positive results from the interim analysis of ZUMA-12, a multicenter, open-label, single-arm phase 2 study evaluating Yescarta (axicabtageneciloleucel) as first-li |
07-12-2020 Omron presents a new wheeze detection device
Omron Healthcare has come up with an automatic wheeze detection device, WheezeScan. It is primarily meant for domestic use and detects the presence of a wheeze in young children.&nbs |
07-12-2020 Omron presents a new wheeze detection device
Omron Healthcare has come up with an automatic wheeze detection device, WheezeScan. It is primarily meant for domestic use and detects the presence of a wheeze in young children.&nbs |
07-12-2020 New COVID-19 testing technique developed by CCMB scientists
The scientists from CCMB (Centre for Cellular and Molecular Biology), Hyderabad, have designed an innovative and most effective COVID-19 testing technique utilizing dry swabs, which |
04-12-2020 MEQU launches a new and improved battery for blood and IV warming devices
MEQU, a Danish Medtech company, announced a new battery for M Warmer System, the compact blood and IV fluid warming device. Appropriately brand named Power Pack, the new battery has |
04-12-2020 CDSCO approves Three GOQii Wearables as Medical Device.
the Central Drugs Standard Control Organization (CDSCO) approved three wearable devices from GOQii for medical device registration. The devices Smart Vital, Vital 3.0, and Vi |
23-11-2020 FDA approval to Baxter's Home Peritoneal Dialysis System
Baxter has received FDA approval for Homechoice Claria with the Sharesource Connectivity platform for adult and pediatric populations. The technology is a home peritoneal dia |
23-11-2020 New AI-Powered Test in IVF Patients: Better Predicts Ongoing Pregnancy and Live Birth Rates
CooperSurgical’s PGTai 2.0 technology is a machine learning AI, with statistical analysis, omitting human subjectivity from the procedure. The technique works by testing embryo |
13-11-2020 Positive results of abrocitinib to treat atopic dermatitis from phase 3 JADE REGIMEN study: Pfizer
Pfizer declared positive results from the phase 3 JADE REGIMEN study. This 52-week study analysed abrocitinib, an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in |
11-11-2020 Positive results from COVID-19 mRNA-based vaccine candidate, BNT162b2's phase 3 study: Pfizer, BioNTech
Pfizer and BioNTech declared their mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 demonstrated efficacy against COVID-19 in participants without prior proof of SARS-CoV-2 |
11-11-2020 NAVIGATOR phase III trial of tezepelumab in asthma patients meets primary endpoints: AstraZeneca and Amgen
AstraZeneca and Amgen declared positive results from the NAVIGATOR phase III trial of tezepelumab in patients with severe, uncontrolled asthma. Tezepelumab is a potential fir |
10-11-2020 Positive results of interim phase 2 study of AP1189 in Rheumatoid Arthritis: SynAct Pharma
SynAct Pharma AB declared positive results of interim phase 2 study in patients with rheumatoid arthritis (RA) with high disease activity to recommend which dos |
10-11-2020 Positive results from denileukin diftitox in patients with cutaneous T cell lymphoma at SITC 2020: Dr Reddy’s Labs
Dr Reddy’s Laboratories declared preclinical data presentation for its engineered IL-2-diphtheria toxin fusion protein, E7777 (denileukin diftitox), at The Society for Immunoth |
10-11-2020 Launch of new brand FitGo: Smart Tech Overseas
Smart Tech Overseas declared a new brand launch, FitGo, to nurture a healthy routine of life worldwide with its modern medical innovations. FitGo's first few products in the |
10-11-2020 Launch of New PHST for catheter-based procedures
Junkosha launched its latest innovation, cut-to-length and slit Peelable Heat Shrink Tubing (PHST), to enable a range of catheter-based procedures where flexibility is the fundamenta |
10-11-2020 Launch of antibody test with 99.9% specificity: Beckman Coulter
Beckman Coulter has launched its Access SARS-CoV-2 Immunoglobulin M (IgM) assay in CE mark accepting countries. The new antibody test demonstrated 99.9% specificity wit |
10-11-2020 Positive results of Nefecon in patients with primary IgA nephropathy from phase 3 NefIgArd trial: Calliditas
Calliditas Therapeutics declared positive results of Nefecon from Part A of the global phase 3 clinical trial NefIgArd, in patients with primary IgA nephropathy (IgAN). The t |
07-11-2020 Positive results from SENSCIS-ON trial evaluating nintedanib in SSc-ILD patients: Boehringer Ingelheim
Boehringer Ingelheim declared positive interim results from the SENSCIS-ON trial evaluating nintedanib in systemic sclerosis-associated interstitial lung disease (SSc-ILD) patients.< |
06-11-2020 Developed affordable high-end ventilators: Nocca Robotics
Nocca Robotics, is developing economical high-end ventilators The company is also working on regulatory aspects to export the Noccarc H210 machines and is on track to deploy |
06-11-2020 Affordable high-end ventilators: Nocca Robotics
Nocca Robotics is developing economical high-end ventilators.The company is also operating on regulatory aspects for Noccarc H210 machines export and is ready to install 400 high flo |
04-11-2020 Inito Fertility Monitor receives USFDA approval
Bengaluru-based medical technology startup Inito's Fertility Monitor had received the United States Food and Drug Administration approval, resulting in the product's launch in the US |
02-11-2020 Biodegradable Patch to Monitor Glucose
|
02-11-2020 Positive results from GENESIS motixafortide phase 3 trial in stem cell mobilization: BioLineRx
BioLineRx Ltd., a biopharmaceutical company, declared positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide in multiple myeloma patie |
02-11-2020 Positive data of Ilumya from pooled reSURFACE 5-year phase 3 extension studies: Sun Pharma
Sun Pharmaceutical Industries Limited declared that one of its subsidiaries presented positive data for Ilumya (tildrakizumab-asmn) from the combined five-year phase 3, reSURFACE 1 r |
01-11-2020 Covid Test Kit Based On RT-LAMP Technology: Agappe Diagnostics
Kochi-based medical devices manufacturer, Agappe Diagnostics Ltd, is launching a new Covid-19 test kit on November 10, based on Reverse Transcription Loop-mediated Isothermal Amplifi |
31-10-2020 Awareness on women's health & breast cancer: HCG in collaboration with Pinkathon
HCG, the cancer care specialist, in collaboration with Pinkathon, hosted The Pink Strong Talks, a live session to create awareness on 'women's health and breast cancer' virtually to |
31-10-2020 PerkinElmer New Coronavirus Nucleic Acid Detection Kit granted Emergency use authorization: US FDA
PerkinElmer, Inc. declared that the US Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA), which allows sample pooling with PerkinElmer New Coronavirus |
31-10-2020 CRISPR-based SARS CoV-2 diagnostic test: Merck collaboration with Mammoth Biosciences
Merck declared collaboration with Mammoth Biosciences for the development, scale-up and commercial production of Mammoth’s CRISPR-based SARS CoV-2 diagnostic test. Mamm |
30-10-2020 Positive results from phase 2/3 COVID-19 outpatient trial of investigational antibody cocktail, REGN-COV2 : Regeneron Pharma
Regeneron Pharmaceuticals Inc declared positive results from an ongoing phase 2/3 COVID-19 outpatient trial analyzing its investigational antibody cocktail, REGN-COV2. The trial resu |
30-10-2020 Triboelectricity based India's first face mask-3bO
Camellia Clothing, a clothing company based in Bangalore, under an exclusive global license from CeNS, has manufactured and is marketing a 3bO face mask. This is India’s first |
29-10-2020 Genbody antigen test kits: ICMR approval
Global Diagnostic firm Genbody Inc has received the Indian Council of Medical Research and Drugs Controller General of India's approval for "Genbody Covid-19 AG" antigen test kits to |
28-10-2020 Cipla collaborates with KARWA Ltd. to launch Covid-19 antibody detection kits in India
Cipla and KARWA Ltd. have collaborated to launch Covid-19 antibody detection kits in India with the brand name ‘ELIFast.’ KARWA ltd. will be responsible for manufacturing |
28-10-2020 Companies to set up mandatory PV cells to generate COVID-19 drugs' ADR data: Health ministry
In the wake of the ongoing pandemic, the Union health ministry has ordered pharmaceutical companies to set up PV (Pharmacovigilance) cells on war footing after due considerations to |
27-10-2020 US FDA's draft norms on PMS quite relevant, Industry claims, as a slew of COVID-19 drugs enter the market
Indian pharma industry sees enough pertinence to the recently released draft guidance on postmarketing obligations by the US FDA. This is because of the COVID-19 drugs |
27-10-2020 Development of powered air-purifying respirators for health workers: SCTIMST
|
26-10-2020 USFDA grants emergency use authorization to South Korea’s Celltrion's Covid test
US Food & Drug Administration (FDA) has approved Celltrion Inc.’s rapid Covid-19 testing kit, Sampinute, for emergency use authorization (EUA). The company initiated the re |
26-10-2020 West Pharma launches Vial2Bag Advanced 20mm Admixture Device after US FDA clearance
US Food & Drug Administration (FDA) granted 510(k) clearance to the Vial2Bag Advanced 20mm Admixture Device from West Pharmaceutical Services Inc. The company has announced its l |
26-10-2020 Bayer's FoundationOneCDx as companion diagnostic for Vitrakvi to aid in identifying NTRK fusion-positive patients: US FDA approval
Bayer's FoundationOneCDx for use as the first companion diagnostic gets US FDA approval for identifying neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients whe |
25-10-2020 ICMR formally announces the approval to use Feluda Paper Strip Test for COVID-19
The Indian Council of Medical Research (ICMR) issued an advisory related to the use of the Feluda paper strip test, by the laboratories, for diagnosis of SARS-CoV-2. The test based o |
24-10-2020 Researchers come up with a new tool to diagnose stroke using a smartphone
Scientists have come up with a novel tool to assist physicians and speed up stroke diagnosis in clinical settings. The new tool based on machine learning may help diagnose stroke and |
23-10-2020 Positive results from phase 3 BRAAVE 2020 study of Biktarvy to treat HIV in black Americans: Gilead
Gilead Sciences declared 48-week data from the BRAAVE 2020 study, a phase 3 clinical trial analysing the efficacy and safety of switching from a standard regimen of two nucleoside re |
23-10-2020 Positive results of phase 1 CARBON trial of CTX110 to treat r/r CD19+ B-cell malignancies: CRISPR Therapeutics
CRISPR Therapeutics, a biopharmaceutical company, declared positive results from the ongoing phase 1 CARBON trial analyzing the efficacy and safety of CTX110, its wholly-owned alloge |
23-10-2020 Tyber Medical's foot and ankle plating systems: USFDA 510(k) clearance
Tyber Medical LLC, a leading orthopedic device manufacturer, received a US Food and Drug Administration (FDA) 510(k) clearance for foot and ankle plating systems. It covers over 42 d |
23-10-2020 Positive data for its COVID-19 vaccine candidate, CVnCoV from preclinical study : CureVac
CureVac N.V., a clinical-stage biopharmaceutical company, declared positive data of its investigational SARS-CoV-2 vaccine candidate, CVnCoV, in mice and hamsters from preclinical st |
17-10-2020 Use of pain and fever medication in pregnancy’s second half could lead to complications: US FDA warning
The USFDA (Food and Drug Administration) releases a Drug Safety Communication regarding labeling changes for nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs such |
17-10-2020 Comprehensive eye care accounts for one-fifth of the global burden of blindness: need of the hour in India
India has one-fifth of the worldwide burden of blindness; hence, comprehensive eye care is the need of the hour, especially children’s eye health, according to experts, specifi |
17-10-2020 Steripath Micro Initial Specimen Diversion Device: Magnolia Medical
Magnolia Medical Technologies Inc, a medical device company, launched the new Steripath Micro Initial Specimen Diversion Device. Micro is the first US FDA 510(k)-cleared devi |
17-10-2020 Anavex's Phase 2 proof of concept study of ANAVEX2-73 for Parkinson's disease dementia announces positive results
Anavex Life Sciences, a clinical-stage biopharmaceutical company, released results from the proof of concept phase 2 controlled trial evaluating the efficacy, safety, and tolerabilit |
16-10-2020 COVID-19 makes access to healthcare difficult for Haemophilia patients
As the national government's primary focus shifted towards COVID-19, the emphasis on healthcare resources, infrastructure, and professionals to treat various other deadly diseases an |
16-10-2020 Novel mitral valve repair technology may come up from Medtronic and Foundry collaboration
The global medical technology company, Medtronic, collaborated with a medical device company incubator, The Foundry, to bring up a novel transcatheter mitral repair technology (TMVr) |
16-10-2020 Rapid diagnosis of Sickle Cell Disease may now be possible using a new Ultrasound device
The University of Colorado researchers have come up with a novel test based on ultrasound technology to detect sickle cell disease. The miniature size of the device, its swift mechan |
16-10-2020 Access to tuberculosis services remains a challenge: WHO report
A report from WHO notifies that access to Tuberculosis (TB) services remains a challenge, and without urgent action and investments, global targets for treatment and prevention will |
15-10-2020 Abbott Healthcare brings its Heart Rhythm Management Devices ICD, CRT-D to India
Abbott Healthcare introduced its new heart rhythm management devices, Implantable Cardioverter Defibrillator (ICD) and Cardiac Resynchronisation Therapy Defibrillator (CRT-D) in Indi |
15-10-2020 FDA issues final guidelines containing biocompatibility draft on Nitinol devices
After reviewing feedback from its advisory committees, AdvaMed and Cook Medical, FDA has concluded the guidelines pertaining to nonclinical assessment of medical devices containing N |
15-10-2020 Tiny Robots designed for targeted drug delivery to Colon and Tissue sampling
Researchers at Purdue University have devised externally controlled tiny robots to precisely deliver the drugs at the targeted area. An external magnetic field is used to control the |
13-10-2020 Semi-Autonomous Colonoscopy using a Robotic Probe is now possible
The University of Leeds researchers have come up with a robotic system to help physicians or nurses perform colonoscopies. It uses magnets for guiding the probe through the body. As |
10-10-2020 "Mann Talks" initiative to counsel individuals on mental health, free of cost
An initiative to build mental strength, "Mann Talks," was launched on October 10, at World Mental Health Day commemoration. The initiative aims to empower individuals suffering from |
09-10-2020 ZEUS ELISA SARS-CoV-2 IgG test system gets EUA approval from USFDA
US Food and Drug Administration (US FDA) granted Emergency Use Authorization (EUA) to ZEUS Scientific's ELISA diagnostic test. The test is used to detect IgG antibodies to the SARS-C |
08-10-2020 USFDA parameters to be used for assessing patients with COVID-19 symptoms for clinical trials
Medical Experts may follow US FDA set norms to evaluate the candidature of individuals with COVID-19 symptoms for clinical trials. The US FDA devised guidelines are being used as ref |
08-10-2020 Many countries witnessing disruption in mental health services due to COVID-19: WHO
Even as the mental healthcare demand is increasing worldwide, 93% of the countries are witnessing disruption in the critical mental health services due to COVID-19. In a survey condu |
08-10-2020 Azure pacemaker with BlueSync technology launched by Medtronic
Medtronic plc's Indian subsidiary India Medtronic Private Limited, launched the Azure pacemaker with BlueSync technology. It is designed to communicate seamlessly with patient's smar |
08-10-2020 4D Pharma's Blautix shows positive results from the phase II BHT-II-002 trial related to irritable bowel syndrome
Blautix, a single strain Live Biotherapeutic from 4D pharma plc for treatment of irritable bowel syndrome (IBS), shows promising results from its phase II BHT-II-002 trial. I |
08-10-2020 Launch of Pressurized Metered Dose Inhaler in India for COPD Patients: Zydus Cadila
Zydus Cadila launched India's first pressurized Metered Dose Inhaler (pMDI), ForglynpMDI, for Chronic Obstructive Pulmonary Disease (COPD) patients in India. With a price tag of Rs. |
06-10-2020 Positive results of phase III HAWK and HARRIER trials of Beovu to treat wet AMD: Novartis
Novartis declares positive results of the phase III HAWK and HARRIER clinical trials in wet age-related macular degeneration (AMD) at the EURETINA 2020 virtual congress. AMD |
06-10-2020 "National Clinical Management Protocol" for COVID-19, based on Ayurveda and Yoga released by the Health Minister
Dr Harsh Vardhan, Union health minister, recently showcased National Clinical Management Protocol based on Ayurveda and Yoga for COVID-19 management. Shripad Yesso Naik (the Minister |
05-10-2020 Ashtel Studios recalls its sanitizers for food like packaging with Iconic images
Ashtel Studios issued a recall notice containing product destruction directions for the hand sanitizer manufactured and distributed by it. The packaging of sanitizer pouches have ima |
03-10-2020 Integration of Ayush Grif with NDHM
The Ministry of AYUSH recently endorsed integrating its digital platform, Ayush Grid, with the National Digital Health Mission (NDHM). The final round of discussions between the Ayus |
03-10-2020 Timely screening of critical diseased like breast cancer and TB affected by Corona pandemic: Fujifilm
The COVID-19 pandemic requires priority diagnosis and treatment of symptomatic patients. The pandemic has sent the national health infrastructure for a toss as the government is dedi |
03-10-2020 SyntheticMR to integrate SyMRI in GE Healthcare's platform
SyntheticMR has collaborated with GE Healthcare to merge its MRI solution SyMRI in GE's platform. The newly integrated platform may provide quicker workflows and complete physiologic |
03-10-2020 WaveWriter Alpha SCS from Boston Scientific will now be available in Europe
Almost the entire range of WaveWriter Alpha Spinal Cord Stimulator (SCS) Systems was officially launched in Europe by Boston Scientific, a global medi-tech giant. It includes four MR |
03-10-2020 Japan PMDA approved Itamar Medical’s WatchPAT 300 home sleep apnea testing device
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) approved the Itamar Medical's WatchPAT 300 Home Sleep Apnea Testing (HSAT) device for commercial launch, effective September |
01-10-2020 Positive Results of Innovational Phase 3 PH1 Trial: Alnylam
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, posts positive results from the pediatric Phase 3 (ILLUMINATE-B) study of lumasiran, an investi |
01-10-2020 Positive Results of Innovational Phase 3 PH1 Trial: Alnylam
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, posts positive results from the pediatric Phase 3 (ILLUMINATE-B) study of lumasiran, an investi |
01-10-2020 Pooled Analysis of Data from two Phase 3 Clinical Trials of Upneeq™ (for Acquired Ptosis): JAMA Ophthalmology
Osmotica Pharmaceuticals plc's subsidiary RVL Pharmaceuticals Inc. stated that its novel medicine Upneeq's Phase 3 clinical trial data was published by JAMA Ophthalmology. Pooled ana |
01-10-2020 ICMR approves Biocard Pro COVID-19 Antigen Rapid Testing Kits from Trivitron
Trivitron Healthcare Private Limited received approval from the Indian Council of Medical Research (ICMR) to launch its 'Biocard Pro COVID-19 Rapid Antigen' testing kits commercially |
29-09-2020 Airborne transmission of SARS-CoV-2:
Researchers at the University of Georgia are supporting the theory of - Airborne transmission of COVID-19 in enclosed spaces. According to their studies, they distinctly supp |
29-09-2020 CardioQuip's heater-cooler device could cause infection, warns FDA.
FDA issued a notice warning the healthcare providers about the risk of infection through using CardioQuip’s heater-cooler device. The device is used to control patients' body t |
28-09-2020 Abbott's latest CGM device, Libre 3, receives CE mark
FreeStyle Libre 3, the latest continuous glucose monitoring (CGM) device from Abbott, received the CE mark, thereby paving the way for its commercial launch in the European market. A |
27-09-2020 Equine Biotech, an IISc start-up, comes up with a Pocket-Friendly RT-PCR kit
Equine Biotech, a start-up of IISc (Indian Institute of Science) students, has developed a novel and affordable Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) diagnostic ki |
25-09-2020 University of Illinois partners with Aequs to bring up mechanical resuscitator
Aequs Force Consumer Products Pvt. Ltd. is coming up with a medical-grade and affordable mechanical resuscitator, AQovent. The company, in collaboration with the University of Illino |
25-09-2020 SeaSpine launches WaveForm C 3D-printed interbody implant system
WaveForm C Interbody Implant System was launched commercially by SeaSpine. The global medical technology giant plans to launch four more devices by mid-2021. The novel WaveFo |
24-09-2020 KardiaMobile 6L, clinically-authenticated exclusive ECG device launched in India by AliveCor
KardiaMobile 6L, the best personal electrocardiogram (ECG) device with US FDA approved ECG technology, was launched by AliveCor in India. It has proven efficacy in detecting atrial f |
24-09-2020 Vela Diagnostic: ViroKey SARS-CoV-2 RT-PCR test v2.0 gets US FDA approval for emergent situations
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to ViroKey SARS-CoV-2 RT-PCR Test v2.0 of Vela Diagnostics. Certain laboratories certified und |
24-09-2020 RTI Surgical's DAC Plate gets USFDA approval under section 510(k)
USFDA granted 510(k) clearance to the RTI Surgical’s Dynamic Active Compression (DAC) plate. Post-approval, the DAC plate has become the first-ever product that may be used to |
23-09-2020 Wipro’s Chitra Air Bridge to be available for breathing assistance anywhere with Wipro 3D and GenWorks partnership
Affordable breathing assistance medical device, Chitra Air Bridge, may become available for all as Wipro 3D ties up with GenWorks Health. As the COVID-19 cases are surging in |
22-09-2020 AR-12 Cancer drug- Aids in fight against SARS-CoV-2:
AR-12 is a powerful drug which has been studied considerably by the Researchers. This drug is an anti- cancer drug which also tends to have anti- viral function. This drug administer |
21-09-2020 Tata group forays into Medical Diagnostics as DGCI approves its economical Covid-19 Test Feluda
The Drug Controller General of India (DCGI) approved the commercial launch of the low-cost COVID-19 test, FELUDA, under strict ICMR guidelines. The test designed by CSIR (Council of |
09-09-2020 Enerzair Breezhaler shows promising results in reducing moderate to severe asthma: Novartis
A single high-dose in a day of Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate [IND/GLY/MF]), from Novartis, is claimed to reduce moderate to |
08-09-2020 Aesthetic medical devices' launch, NuEra Tight with FocalRF for personalized body sculpting treatments: Lumenis
The largest energy-based medical device company, Lumenis Ltd., announces the launch of revolutionary NuEra Tight with FocalRF technology, in the Middle East and Europe for body sculp |
05-09-2020 Positive results of Vadadustat to treat anemia due to CKD in adult patients from PRO2TECT phase 3 program: Akebia Therapeutics
Akebia Therapeutics Inc, a biopharmaceutical company, declared positive results of vadadustat, oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) from PRO2TECT, the |
05-09-2020 Elicited Antibody Response, with no Serious Adverse Events In phase 1/2: Russian Vaccine for preventing COVID-19 infection
The paper published in Lancet states the findings of two open-label, Russian non-randomized phase 1/2 trials (Sputnik V) looking at a freeze-dried formulation and a frozen formulatio |
04-09-2020 Non-invasive medical instruments for pain relief in India : OSKA India
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
|
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 |
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 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
|
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
|
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: FitbitFitbit, 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
|
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
|
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
|
06-03-2020 CryoLife receives CE Mark for E-vita Open NEO hybrid stent graft
|
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
|
05-03-2020 Merck introduces LANEXO system to increase productivity of scientists in laboratory
|
05-03-2020 Elecsys GALAD score of Roche gains US FDA breakthrough device designation to diagnose HCC
|
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
|
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
|
17-01-2020 Team discovers a way to eliminate GI device without the usage of endoscopy
|
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
|
14-01-2020 Clearance of new AI system from FDA for spotting stroke
|
14-01-2020 Phagenesis gains FDA breakthrough green light for Phagenyx System for restoring swallowing
|
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
|
13-01-2020 Breakthrough Therapy Designation filed by CytoDyn with the FDA for the Utilization of Leronlimab to treat Metastatic Triple-Negative Breast Cancer
|
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
|
10-01-2020 URO17 bladder cancer recurrence test of KDx Diagnostics obtains USFDA breakthrough device designation
|
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
|
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
|
08-01-2020 USFDA grant approval to Abbott's HeartMate 3 heart pump to aid patients avoid open heart surgery
|
07-01-2020 Cognetivity Neurosciences declares regulatory approval of 1st CE-marked medical device
|
07-01-2020 FDA grants 510(k) clearance for handheld OCT scanner of PhotoniCare
|
07-01-2020 Bioness gains CE Mark approval for StimRouter system
|
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
|
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
|
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
|
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
|
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
|
25-12-2019 Implants specific to patients are developed at Central Scientific Instruments Organisation
|
24-12-2019 FDA clearance secured by Life Spine to market Titanium Stand-Alone ALIF Spacer System
|
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
|
24-12-2019 A preoperative blood test may anticipate risk of cardiac complications after surgery
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
|
23-12-2019 Recalling of vagus nerve implant by LivaNova amid reset issues
|
22-12-2019 Prevention of ICU delirium and improvement in patient outcomes led by new developed software
|
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
|
22-12-2019 Novel AI app may prohibit patients from severe falls
|
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
|
20-12-2019 Bristol-Myers Squibb obtains USFDA approval for CAR T cell therapy for treatment of LBCL patientsBristol-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
|
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
|
19-12-2019 AiMeD praised proposed medical devices bill by Niti Aayog to consider patient safety
|
19-12-2019 FDA breakthrough nod secured for Mayo Clinic which has AI-based heart failure screening from Eko
|
19-12-2019 FDA advises Conformis over sterilization cycle failures
|
19-12-2019 Breakthrough status granted to Eko’s ECG-based algorithm by FDA
|
19-12-2019 Medfusion® 4000 Syringe Pumps Recalled by Smiths Medical ASD, Inc. Due to Malfunctioning Alarms and Potential Interruption of Therapy
|
18-12-2019 FDA Clearance obtained by TAP At-Home Blood Collection System
|
18-12-2019 FDA Clearance for Cranial Procedures of Medtronic Stealth Autoguide System
|
17-12-2019 AI-driven prostate launched by Anixa Biosciences for cancer detection test
|
17-12-2019 CE Mark obtained by Aleva Neurotherapeutics for brain stimulation systemAleva 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
|
17-12-2019 OmniBeds and Giraffe Incubators are recalled by GE Healthcare Recalls Due to Potential for Infants to Fall
|
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
|
16-12-2019 Tandem gains FDA clean chit for 1st interoperable, automated insulin software for dosing
|
16-12-2019 Boston Scientific receives first US disposable duodenoscope clearance
|
16-12-2019 SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic
|
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
|
13-12-2019 FDA grants tool for evaluating safety of implanted devices
|
13-12-2019 SynchroMed II Implantable Drug Infusion Pump Recalled by MedtronicDue 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. |
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. |
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
|
10-12-2019 FDA scores novel Medtronic SynchroMed II call back as Class I event
|
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 |
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
|
05-12-2019 afib device of Boston Scientific efficient in reduction of stroke
|
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.
|
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. |
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
|
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: USFDAMinimally 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 IndiaA 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 testThe 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 PAHA 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 surveyThere 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: OrchestraOrchestra 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 balloonFDA 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 AVFConcept 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 government10 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 scoliosisThe 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, LLCThe 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. RecalledAn 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 approvalThe 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 approvalThe 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 inspectionThe 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 scoliosisThe 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 approvalThe 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 USFDAThe 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/S085The 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 approvalBarostim 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 FailureA 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 KabiFresenius 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 stentMeril 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/S058Both 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 100Seraph 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 DefibrillatorsImplantable 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 approvalSysmex 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 approvalSysmex 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: CDSCOAccording 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 results1500 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 EnvironmentA 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 generalA 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/S014The 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 HillromHillrom 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 easyThe 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 ElectrodesIn 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 MonitorLong-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 compressionsIt 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: EMAA 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 SabhaAnand 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 pregnancyThe 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 FDAThe 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 IndiaIndian 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 NATHEALTHNational 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 IndiaAs 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 MinisterVishwajit 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 patientsMedtronic 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 ministryA 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 warningThe 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 diagnosisAn 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 FranceThe 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 MaquetThe 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 softwareMedtronic, 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 FDAMed-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 vaccinesAccording 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: FDAAirDuo 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 |