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 |
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 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 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, |
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 |
10-11-2020 EUA to cPass SARS-CoV-2 neutralization antibody detection kit of GenScript: USFDA
GenScript USA Inc. declared that the USFDA had issued Emergency Use Authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit. This kit is the first commerci |
10-11-2020 EUA to cPass SARS-CoV-2 neutralization antibody detection kit of GenScript: USFDA
GenScript USA Inc. declared that the USFDA had issued Emergency Use Authorization (EUA) for the cPass SARS-CoV-2 Neutralization Antibody Detection Kit. This kit is the first commerci |
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 |
06-11-2020 Developed affordable high-end ventilators: Nocca Robotics
Nocca Robotics, is developing economical high-end ventilators The company is also working on regulatory aspects to export the Noccarc H210 machines and is on track to deploy |
06-11-2020 Affordable high-end ventilators: Nocca Robotics
Nocca Robotics is developing economical high-end ventilators.The company is also operating on regulatory aspects for Noccarc H210 machines export and is ready to install 400 high flo |
04-11-2020 Inito Fertility Monitor receives USFDA approval
Bengaluru-based medical technology startup Inito's Fertility Monitor had received the United States Food and Drug Administration approval, resulting in the product's launch in the US |
02-11-2020 Biodegradable Patch to Monitor Glucose
Anna University researchers have developed a biodegradable material, a cellulose derivative-based polymer, for detecting glucose and alcohol levels from sweat to reduce medical waste |
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 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 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 |
27-10-2020 Development of powered air-purifying respirators for health workers: SCTIMST
The Sree Chitra Tirunal Institute for Medical Science and Technology (SCTIMST), a Thiruvananthapuram-based Centre of Excellence under the Department of Science and Technology (DST), |
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 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 |
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 |
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 |
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 |
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 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 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. |
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 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 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 MedSpark- The first Medical Device Park in India
Kerala - First state of India to possess the first Medical Device Park in the country. Recently, the foundation stone of the MedSpark Medical Device Park was laid by the honorab |
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 |
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 |
04-09-2020 Non-invasive medical instruments for pain relief in India : OSKA India
OSKA Wellness launched 'OSKA Pulse'; PEMF (Pulsed-Electromagnetic-Field-Therapy) technology-enabled products, in India. The company is the first enabler of this innovative te |
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 |
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 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 |
28-08-2020 Guidelines to conduct COVID-19 screening in TB patients: Health ministry
The Union health ministry releases guidelines stating that tuberculosis (TB) screening will be done for all COVID-19 positive patients and COVID-19 screening will be done for all TB |
28-08-2020 New workflow and imaging enhancements for Kodex-EPD cardiac mapping and imaging system for heart rhythm disorders: Philips
Royal Philips announces new imaging and workflow enhancements for its novel Kodex-EPD cardiac imaging and mapping system. The system treating a common heart rhythm disorder,&nbs |
28-08-2020 Launch of High-Flow Oxygen Therapy Device, Noccarc H210 for critical COVID-19 patients: Nocca Robotics
Nocca Robotics Pvt Ltd, of SIIC, IIT Kanpur, launched a clinically validated and certified High- Flow Oxygen Therapy Device for COVID-19 patients. The device is high-quality critical |
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 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 e
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26-08-2020 India’s first-ever rapid diagnostic test kit for Covid-19 gets ICMR approval
Delhi based Oscar Medicare Pvt. Ltd. that manufactures various in-vitro diagnostic kits have developed a simple, single prick rapid testing kit for detecting COVID |
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 |
23-08-2020 High-flow nasal oxygen (HFNO) method seems to be crucial during COVID
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22-08-2020 Leven Medical: India-Dutch collaborative startup announces smart ventilators with AI ML
The smart ventilators can auto adjust patient's oxygen flow. In emergent cases, these send alerts to the concerned medical staff and to family members. The startup claims that the ve |
20-08-2020 Smart wearable devices may detect COVID-19 even before the symptoms: Fitbit
Fitbit, a leading manufacturer and marketer of health-tracking watches, launched a study aiming to create an algorithm to detect COVID-19 before symptoms appeared. Out of the 100,000 |
12-03-2020 USFDA grants CINtec PLUS Cytology test of Roche for screening of cervical cancer
Roche was awarded by US Food and Drug Administration (FDA) grant for CINtec PLUS Cytology for the 1st biomarker-based triage test for women whose primary cervical cancer sc |
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 XCR Diagnostics receives US patent for technology that expedites testing and recognition of infectious diseases
A molecular diagnostics company known as XCR Diagnostics has been granted a patent by the United States Patent and Trademark Office (US PTO) for its technology that expedit |
08-03-2020 Silfradent Srl received warning letter
An inspection has been performed at firm located in Santa Sofia, Forli-Cesena, Italy, on July 29, 2019 to August 1, 2019, an investigator from the United States Food and Dr |
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 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 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 SCTIMST creates intracranial flow diverter stent for treatment of aneurysms of blood vessels of brain
The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, which is an institute of national importance, has created an innovative intr |
06-03-2020 CryoLife receives CE Mark for E-vita Open NEO hybrid stent graft
A leading cardiac and vascular surgery company known as CryoLife, Inc., committed on aortic disease, declared that it has achieved CE Mark for the E-vita Open NEO, a hybrid sten |
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 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 Draft Medical Devices Bill for stakeholders review soon will be circulated by Niti Aayog
To talk about the regulatory vacuum and issues of patient safety in medical devices, Niti Aayog is likely to spread a draft of the Medical Devices Bill for stakeholders review to fra |
05-03-2020 Merck introduces LANEXO system to increase productivity of scientists in laboratory
A leading science and technology company, Merck, inaugurate its LANEXO Lab Inventory, safety and compliance management system which is a new digital laboratory informatics solut |
05-03-2020 Elecsys GALAD score of Roche gains US FDA breakthrough device designation to diagnose HCC
Roche declared that the US Food and Drug Administration (FDA) has approved Breakthrough Device Designation to the Elecsys GALAD score. This algorithmic score cumulates gender and age |
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 Birth
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 |
29-02-2020 Avanos receives FDA clearance for COOLIEF Radiofrequency system
Avanos Medical has gained clearance from the US Food and Drug Administration (FDA) for selling its 80W COOLIEF Radiofrequency (RF) system for neurological lesion procedures |
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 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 |
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 |
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 |
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 |
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 |
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 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 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 |
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 |
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 |
17-01-2020 Siemens reveals medical manufacturing centre in Bangalore
Siemens Healthineers which is a medical technology company has initiated its first manufacturing facility in Bengaluru, which will complement its existing R&D centre. T |
17-01-2020 Novel 'smart' chair aids in correcting body posture from childhood
The concept of the current study is already submitted in the conference materials furnished by the French publishing house Atlantis Press, contented by the Scopus and |
17-01-2020 Team discovers a way to eliminate GI device without the usage of endoscopy
Scholars at Massachu |
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 Pentax Medical receives FDA approval for IMAGINA endoscopy system
A unit of Hoya Group, Pentax Medical, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its IMAGINA endoscopy system. The endoscopy platform wa |
14-01-2020 Medtronic gains CE Mark approval for InterStim products
Medtronic which is Irish medical device maker has secured CE Mark approval for its InterStim Micro neurostimulator and InterStim SureScan MRI leads. By giving full-body MRI s |
14-01-2020 Clearance of new AI system from FDA for spotting stroke
501(k) clearance has been granted to the US Food and Drug Administration (FDA) for radiology company Aidoc’s AI-based system for the recognition of large-vessel occlusion (LVO) |
14-01-2020 Phagenesis gains FDA breakthrough green light for Phagenyx System for restoring swallowing
Phagenesis declared that it has secured breakthrough device designation from the FDA for its Phagenyx System for restoring neurological swallowing control. The Phagenyx Syste |
13-01-2020 New Guidance advertised on Medical Devices and Cybersecurity
New European medical device guidance will need manufacturers to carefully review IT security and cybersecurity needs in relation to their devices and in their product literature |
13-01-2020 Breakthrough Therapy Designation filed by CytoDyn with the FDA for the Utilization of Leronlimab to treat Metastatic Triple-Negative Breast Cancer
A late-stage biotechnology company known as CytoDyn Inc. is committed on developing leronlimab (PRO 140), a CCR5 antagonist with the capability for multiple therapeutic ind |
10-01-2020 Researchers created AI system to locate and grade prostate cancer
Researchers have created a method addressed on artificial intelligence (AI) for diagnosis and grading of prostate cancer. |
10-01-2020 URO17 bladder cancer recurrence test of KDx Diagnostics obtains USFDA breakthrough device designation
KDx Diagnostics, a company committed on developing non-invasive cancer tests to enhance early detection and therapy decisions in cancer, declared that the Food and Drug Adm |
10-01-2020 Silver Bullet achieves CE Mark for antimicrobial bone screw system
Silver Bullet Therapeutics which is US-based medical device company has gained CE Mark approval for the commercial sale of its antimicrobial bone screw system in the European Union ( |
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 |
08-01-2020 Abbott obtains FDA approval for procedure of heart pump implant
Abbott has gained approval from the US Food and Drug Administration (FDA) for its minimum invasive heart pump implant procedure to assist patients in avoiding open heart surgery |
08-01-2020 USFDA grant approval to Abbott's HeartMate 3 heart pump to aid patients avoid open heart surgery
Abbott declared that the US Food and Drug Administration (FDA) has granted approval to a new alternative surgical technique for Abbott's HeartMate 3 heart pump that will permit |
07-01-2020 Cognetivity Neurosciences declares regulatory approval of 1st CE-marked medical device
Cognetivity Neurosciences Ltd. declared that its Integrated Cognitive Assessment (ICA) software has been granted as a CE-marked medical device. The declaration follows Cognetivi |
07-01-2020 FDA grants 510(k) clearance for handheld OCT scanner of PhotoniCare
510(k) clearance for PhotoniCare’s TOMi Scope has been granted by the US Food and Drug Administration (FDA) for non-invasive imaging of the middle ear to diagnose ear infe |
07-01-2020 Bioness gains CE Mark approval for StimRouter system
Bioness, a US-based medical technology company has gained CE Mark approval for its StimRouter neuromodulation system for treatment faecal incontinence. The small implant |
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 |
30-12-2019 MyShoulder placement guides of Medacta cleared by FDA
Medacta obtains FDA clearance for their MyShoulder Placement Guides for shoulder arthroplasty. This patient-compatibility, 3D printed solutions work in co-existence with the Medacta |
28-12-2019 IIT-Roorkee makes a bioresorbable, economical ortho implants for healing of bone fractures
Scholars and researchers at the Indian Institute of Technology (IIT), Roorkee have made bioresorbable and economical orthopaedic implants to heal bone fractures. The recent s |
27-12-2019 Invention of cost-effective bio-resorbable orthopaedic implants by IIT Roorkee for healing bone fractures
Invention of cost-effective bio-resorbable orthopaedic implants for healing bone fractures were done by the researchers of IIT Roorkee. The recent strategies of therapeutic to h |
26-12-2019 Ultrasound along with MRI enhances prostate treatment
MRI-guided transurethral ultrasound ablation (TULSA) is a novel tool for the highly precise treatment of prostate cancer — without the common side effects. Scans of ultras |
26-12-2019 First indigenous CT-scanner shipped by Siemens Healthineers from its new Bengaluru facility
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26-12-2019 For 24 hours health monitoring tiny microsensor implants has been developed
Researchers at National University of Singapore (NUS) have created tiny subcutaneous implants that can continuously quantify a heart rate, blood sugar and other physiological conditi |
25-12-2019 Implants specific to patients are developed at Central Scientific Instruments Organisation
Jaw and bone implants specific with patients can now be developed and created within the country, inside IARM (innovative additive research and manufacturing) laboratory establi |
24-12-2019 FDA clearance secured by Life Spine to market Titanium Stand-Alone ALIF Spacer System
FDA 510(K) Clearance secured by Life Spine for the Titanium Stand-Alone ALIF System. It is the 7th product of the company to obtain FDA approval this year. The Tita |
24-12-2019 As per 2013 standards Accu-Chek blood glucose monitoring systems are in compliance with latest IS/ISO 15197
Roche Diabetes Care (RDC) India declared that its Accu-Chek brand of blood glucose monitoring products are in compliance with the revised standards of IS/ISO 15197:2013. It has |
24-12-2019 A preoperative blood test may anticipate risk of cardiac complications after surgery
The number of surgical interventions is on the elevation and together there is an enhancement in number of postoperative complications. Of all the patients who have undergone |
23-12-2019 New Software System for Insulin Control was granted by FDA
Tandem Diabetes Care has secured approval in the US for a new software system that can be utilized in “artificial pancreas” systems to automatically measure blood glucose |
23-12-2019 Recalling of vagus nerve implant by LivaNova amid reset issues
LivaNova is calling back its vagus nerve stimulation (VNS) device that is implanted in patients for treatment of major depressive episodes and to control seizures related with epilep |
22-12-2019 Prevention of ICU delirium and improvement in patient outcomes led by new developed software
Intensive care unit delirium which is a fertile area of clinical research and patient care innovation related with Vanderbilt University Medical Center, is initiating to reshape how& |
22-12-2019 Novel genetic test may anticipate ischemic stroke at birth
Major cause of death and permanent disability worldwide is stroke. About 80% of strokes are “ischemic” — meaning, they are caused due to the blockage of an artery t |
22-12-2019 Novel AI app may prohibit patients from severe falls
A novel machine learning app has been created for prohibiting patients from severe fall-related injuries and deaths. Houston Methodist have created novel AI technology whic |
20-12-2019 Renewed CE mark gained by IRRAS for IRRAflow catheter
IRRAS received CE mark approval for its IRRAflow catheter. The new approval is gained after the company obtained 2 CE marks for its IRRAflow system’s tube set with a digital pu |
20-12-2019 Recalling device by LivaNova for treatment of seizures, depression
Recalling of device by LivaNova is done which is London medical device-maker that helps in treatment of adults and children over 4 years old with partial onset seizures that hav |
20-12-2019 Bristol-Myers Squibb obtains USFDA approval for CAR T cell therapy for treatment of LBCL patients
Bristol-Myers Squibb Company declared the filing of its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for lisocabtagene maraleucel (liso-cel
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20-12-2019 EB19-J10U Ultrasound Video Bronchoscope released by PENTAX in United States
PENTAX received the USFDA clearance for its new EB19-J10U endobronchial scope. The device, proposed for minimally invasive procedures such as EBUS-guided Transbronchial Needle A |
19-12-2019 Testing Clearance in EU for FINDER Device for Bedside G6PD Deficiency
Baebies has secured the CE Mark for its FINDER device, paving the way for Europe introduction. The device can render in identifying Glucose-6- Phosphate Dehydrogenase (G6PD |
19-12-2019 AiMeD praised proposed medical devices bill by Niti Aayog to consider patient safety
Association of Indian Medical Device Industry (AiMeD) praised proposed medical devices bill by Niti Aayog to consider safety of patient and import dependency issues. Its objecti |
19-12-2019 FDA breakthrough nod secured for Mayo Clinic which has AI-based heart failure screening from Eko
Eko which is Digital Health Company secured breakthrough device designation from FDA for priority review of the algorithm to detect heart failure of company with a specialized stetho |
19-12-2019 FDA advises Conformis over sterilization cycle failures
FDA proclaimed regarding a warning letter to Conformis, a Massachusetts-based customized joint implant manufacturer, quoting sterilization issues regarding the knee replacement syste |
19-12-2019 Breakthrough status granted to Eko’s ECG-based algorithm by FDA
Eko Devices which is a digital health firm has gained breakthrough device designation from the US Food and Drug Administration (FDA) for its ECG-based low ejection fraction screening |
19-12-2019 Medfusion® 4000 Syringe Pumps Recalled by Smiths Medical ASD, Inc. Due to Malfunctioning Alarms and Potential Interruption of Therapy
The FDA has recognized the recall as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality. The Smiths Medi |
18-12-2019 FDA Clearance obtained by TAP At-Home Blood Collection System
Seventh Sense Biosystems secured FDA clearance for its TAP device to be utilized by laypersons for collection of blood.The device is now given green signal to be utilized at home by |
18-12-2019 FDA Clearance for Cranial Procedures of Medtronic Stealth Autoguide System
A cranial robotic platform from Medtronic which is the Stealth Autoguide has been given clearance by the FDA. The system renders accurate and partially automatic positioning and adva |
17-12-2019 AI-driven prostate launched by Anixa Biosciences for cancer detection test
Anixa Biosciences has commercially introduced Cchek Prostate Cancer Confirmation (Cchek PCC) test. The low-cost blood test is considered to accurately identify the existence of cance |
17-12-2019 CE Mark obtained by Aleva Neurotherapeutics for brain stimulation system
Aleva Neurotherapeutics has obtained CE mark for its directSTIM Deep Brain Stimulation (DBS) system. The DBS system technology permits accurate steering of current towards the desi
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17-12-2019 AI assisted polyp detector of Pentax Medical, Discovery obtains CE marking
A division of the Hoya Group, Pentax Medical received CE mark for Discovery, an innovative Artificial Intelligence (AI) assisted polyp detector structured to support endoscopists in |
17-12-2019 OmniBeds and Giraffe Incubators are recalled by GE Healthcare Recalls Due to Potential for Infants to Fall
The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality. Warmers an |
17-12-2019 CrossCath® Support Catheters recalled by Cook Medical Due to a production Error Which May Cause the Marker Bands to Dislodge or Cause hooking
The FDA has recognized this as a Class I recall which is the most serious type of recall. Utilization of these devices may cause morbidity or mortality. The CrossCath&re |
16-12-2019 Zika blood screening test introduced by Roche
Roche has declared the launch of its cobas Zika test to markets that are in compliance with the CE mark. The cobas Zika test, which is proposed for use in screening blood donati |
16-12-2019 Tandem gains FDA clean chit for 1st interoperable, automated insulin software for dosing
FDA granted the third and final type of diabetes management technology necessary for a wholly inter-operable, automated insulin system for dosing. |
16-12-2019 Boston Scientific receives first US disposable duodenoscope clearance
510(k) clearance was granted by FDA to the 1st ever wholly disposable duodenoscope which is a device developed by Boston Scientific. |
16-12-2019 SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic
Currently, FDA released a report that Medtronic has recalled its SynchroMed II implantable drug infusion pump, part of the SynchroMed Infusion System, after obtaining reports of |
13-12-2019 FDA Approves First Disposable Duodenoscope which Reduces Risk of Infection
When duodenoscopes which are utilized for diagnosis of illness in the pancreas and bile ducts are not cleaned properly, can cause hundreds of cases of severe, sometimes fatal, infect |
13-12-2019 FDA grants tool for evaluating safety of implanted devices
An announcement was done regarding FDA securing a tool which is created to make it simpler for developers of active implantable medical devices (AIMDs) to make safety test results. |
13-12-2019 SynchroMed II Implantable Drug Infusion Pump Recalled by Medtronic
Due to the potential availability of Foreign Particles Inside the Pump Motor Assembly Which May result in Pump Motor Stall Part of the SynchroMed Infusion System which is known as
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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. |
11-12-2019 LimaCorporate, TechMah Medical obtain USFDA 510k approval for Smart SPACE Shoulder 3D Planner & 3D Positioner
A global medical device company known as LimaCorporate obtains the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Being an innovative digital platform, Sm |
11-12-2019 Breakthrough designation to Beta Bionics for blood sugar device
Breakthrough device designation status has been obtained by Beta Bionics from the US Food and Drug Administration (FDA) for its iLet Bionic Pancreas System. iLet Bionic Pancreas is a |
11-12-2019 CE mark received by Roche for blood glucose monitoring app
CE mark has been granted to Roche for its smartphone app that permits users to quantify blood glucose level without the requirement of a meter. This is known as Accu-Chek SugarVie. T |
11-12-2019 FDA labelled breakthrough device to Beta Bionics' pancreas tech
Boston-based medtech Beta Bionics received FDA Breakthrough Devices Program for its iLet system, which utilizes mathematical algorithms for dosing to automatically control blood suga |
10-12-2019 FDA scores novel Medtronic SynchroMed II call back as Class I event
As per the reports released by agency, FDA classified a Medtronic voluntary call back of certain SynchroMed II implantable drug infusion pumps as a Class I event. The recall, |
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 |
05-12-2019 FDA clearance obtained by Sight Diagnostics for Olo blood analyser
Sight Diagnostics had obtained clearance from the US Food and Drug Administration (FDA) for its Olo blood analyser, which is able to process results for a complete blood test i |
05-12-2019 BioPrax, Infection-Eradicating was tagged ‘Breakthrough’ by USFDA
“Breakthrough Device” designation has been granted to Garwood Medical Devices, LLC, from the U.S. Food and Drug Administration (FDA) for the BioPrax device of the company |
05-12-2019 Surgical robot of Vicarious obtains breakthrough status by FDA
Vicarious has managed to secure breakthrough device status from FDA for Surgical's robotic surgical system. The status, is the 1st awarded to a surgical robot, blankets technology st |
05-12-2019 afib device of Boston Scientific efficient in reduction of stroke
FDA-mandated registries had 2 long-term studies which are associated to Boston Scientific's left atrial appendage closure device known as Watchman, to vital reductions in stroke risk |
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.
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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 Impulse Device receives PMA approval from FDA for heart failure device
PMA supplement approval was received by Impulse Dynamics for its next-generation; two lead Optimizer Smart System for treatment of heart failure by the US Food and Drug Administratio |
30-10-2019 Medical Device Developments: Finalization of Four 510(k) Guidance Documents by FDA
The U.S. Food and Drug Administration furnished multiple final guidance documents related to the medical device program. Here are the four guidance documents: final guidances on the |
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 |
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 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 |
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 |
23-08-2019 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 |
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 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 |
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 sub |
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 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
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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 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 |
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.
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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 |
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 |