Archive for September 2020
Minnetronix Medical Wins FDA Clearance for Innovative Neurosurgical Access Platform
Minnetronix Medical, the company known for 25 years of developing and manufacturing products for medical device companies throughout the world, today announced that it has received FDA clearance for its first platform product: the MindsEye™ Expandable Port for neurosurgical procedures. This clearance represents an expansion of the company’s traditional offerings to include market-ready platforms. The…
Read MoreMedtronic Tricuspid Valve Replacement Device Wins FDA Breakthrough Status
Medtronic, a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back…
Read MoreFujifilm Sonosite Receives FDA COVID-19 510(k) Clearance for Point-of-Care Ultrasound Portfolio
FUJIFILM Sonosite, Inc., specialists in developing cutting-edge point-of-care ultrasound (POCUS) solutions, and part of the larger Fujifilm Healthcare portfolio, today announced that the company has received 510(k) Clearance from the U.S. Food & Drug Administration (FDA) for the company’s entire POCUS portfolio to support healthcare providers in performing accurate lung and cardiac imaging in COVID-19 patients. Fujifilm…
Read MoreCryoLife Acquires Ascyrus Medical
CryoLife, Inc., a leading cardiac and vascular surgery company focused on aortic disease, announced today that it has acquired Ascyrus Medical LLC. Ascyrus is a Florida-based, privately-held developer of the Ascyrus Medical Dissection Stent, the world’s first aortic arch remodeling device used for the treatment of acute Type A aortic dissections. The addition of the…
Read MoreAdvaMed Commends Proposed CMS Rule to Cover “Breakthrough” Medical Devices
Following today’s issuance by the Centers for Medicare and Medicaid Services (CMS) of a proposed rule on Medicare coverage of innovative technologies, the Advanced Medical Technology Association (AdvaMed) issued the following statements from President and CEO Scott Whitaker and other medtech industry leaders commending the agency’s action: “In order to incentivize innovative medical breakthroughs, the…
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