U.S. Approval of the First and Only Nitinol Atherectomy Guide Wire Expands Company’s Portfolio of Products Targeting Complex Coronary Disease ...
Medtronic plc (NYSE:MDT), a global leader in heart valve therapies, today announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut PRO+ TAVR System – a new-generation Medtronic TAVR system that builds off the proven self-expanding, supra-annular Evolut TAVR platform....
Viseon, Inc. today announced US FDA clearance and initial clinical use of their Voyant System, integrating minimally invasive surgical (MIS) access with real time high definition imaging technology for more efficient procedural workflow, which enhances a clinician’s intraoperative visualization, providing a more accurate, precise ...
Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin delivery and diabetes technology company, today announced publication of real-world data from more than 8,000 users of the t:slim X2™ insulin pump with Basal-IQ® predictive low-glucose suspend technology in the medical journal Diabetes Technology and Therapeutics...
MannKind Corporation (NASDAQ: MNKD) announced that data from a one-year study of Afrezza (insulin human) Inhalation Powder was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain....
Stimwave Technologies, the leading innovator of wireless medical device bioelectronic technology, in honor of September Pain Awareness Month, today announces the launch of a new randomized clinical trial treating painful peripheral neuropathy, the “SMOOTH” study....
The CoreLink Oro Lateral Plate System provides a low-profile solution for lateral lumbar plating featuring an automatic locking mechanism to prevent screw back-out and the ability to connect to the CL5 & F3D Lateral interbodies for enhanced operating room efficiency. (Photo: Business Wire) ...
Apollo Endosurgery, Inc. (“Apollo”) (Nasdaq:APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Polypropylene Suture-Anchor Assembly...
Foldax, Inc. today announced its first-in-human use of the Tria heart valve under its FDA Early Feasibility Study (EFS) for the treatment of aortic valve disease. Clinicians at Beaumont Hospital, Royal Oak, in Michigan, implanted this innovative flexible polymer heart valve,...
The U.S. Food and Drug Administration (FDA) has cleared the ARTIS icono, a high-precision family of angiography systems from Siemens Healthineers that permit a wide range of minimally invasive procedures to be performed in a single interventional suite. ...