Medical Device Approval Articles & Analysis
32 news found
The medical sterilization bag is a medical device approved by the Food and Drug Administration. ...
Mr. Belteau joins enVVeno Medical following a twenty-three-year career in clinical operations at Medtronic. ...
AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH) (the “Company”), a regenerative medicine company that is developing and commercializing a technology platform that enables point-of-care autologous skin restoration for multiple unmet needs, today reported financial results for its first quarter ended March 31, 2022. Financial Highlights and Recent Updates: Reported ...
EchoPixel’s True3D software platform, a pre-operative planning technology that creates a hologram of the heart for study before an incision is ever made, has received PMDA Medical Device Registration and Approval in Japan. This first-of-its-kind software enables the entire heart surgical team to develop a precise personalized plan by ...
Pharmacy and Hospital Automation Solution provider JVM became an Integrator of Codonics Safe Label System to deliver more complete anesthesia medication management solutions to operating rooms in hospitals worldwide. JVM, a subsidiary of Hanmi Pharmaceuticals and leading global provider of pharmacy and hospital automation solutions including ATDPS and INTIPharm, today announced its integrator ...
ByCodonics
(NASDAQ:CYTO), a company dedicated to addressing unmet medical needs through RNA therapeutics, allergy and viral infection protection, and inner ear therapeutics announced today that Bentrio™ has been approved by the Medical Device Authority of Malaysia and is, therefore, cleared for commercialization in that country. ...
ClaroNav Kolahi Inc (CKI) is pleased to announce that it has received Health Canada approval for its Navient ENT and Navient Cranial as Class III medical devices. Previously both devices had been approved as Class II devices. “Navient is one of the very few image guided navigation systems ...
ByClaroNav
Reflow Medical, Inc., a California- based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading ...
Medscape Letter Regarding Avery System Avery Biomedical Devices has an outstanding track record spanning over 45 years including an outstanding safety record, long term viability with some patients pacing for more than 35 years, and exceptional patient satisfaction. It is also the only device of its kind with full FDA premarket approval and CE ...
Signifier Medical Technologies, an innovator in the sleep disordered breathing market, today announced that eXciteOSA®, the first and only daytime intraoral neuromuscular stimulation device for treating mild obstructive sleep apnea and snoring, has received the prestigious GOOD DESIGN® Award in the Medical category. The ...
Impulse Dynamics, an international medical device company dedicated to improving the lives of people with heart failure (HF), today announced that DEKRA Certification B.V. (DEKRA), a global regulatory organization, approved labeling for the Optimizer® Smart device for conditional full-body MRI scans utilizing 1.5 ...
QuarkBio’s DigiChip™ SARS-CoV-2 Assay Kit has received manufacturing approval from Taiwan Ministry of Health and Welfare as part of the “Approved List of Medical Device Manufacturing Application for SARS-CoV-2”. The approval period is from November 23, 2020, to December ...
MiniTC is a disposable, closed loop medical device that can be used in the clinic setting, with no change in infrastructure, eliminating the need for manual processing of fat tissue in the lab. ...
” MiniTC is a disposable, closed loop medical device that can be used in the clinic setting, with no change in infrastructure, eliminating the need for manual processing of fat tissue in the lab. ...
MINNEAPOLIS, Nov. 2, 2020 - CVRx®, developer of the world's first FDA-approved neuromodulation device to treat chronic heart failure (HF), announces that its BAROSTIM NEO™ implantable device has received the Centers for Medicare & Medicaid Services (CMS) inpatient New Technology Add-On Payment (NTAP). ...
ByCVRx
This is the first medical wristwatch to receive medical regulatory approval for beat by beat heart rate monitoring and A-Fib detection with ECG accuracy The approval allows the company to start selling its medical watch to patients in Israel requiring continuous heart rate monitoring. ...
Adagio Medical, Inc. (Adagio), the developer of iCLAS™, the company’s ultra-low temperature intelligent continuous lesion ablation system, announced that it has received an Investigational Device Exemption approval with conditions from the US Food and Drug Administration (FDA) to conduct a non-randomized, single-arm clinical study for ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional, biobased, and nanoscale basic, specialty, and agricultural and ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional, biobased, and nanoscale basic, specialty, and agricultural and ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional and nanoscale basic, specialty, and agricultural and antimicrobial ...