The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc. Read More
Merit Medical Systems Inc. reported it is buying the lead management assets of Cook Medical Inc. for $210 million in cash. The Cook products consist of lead extraction devices and other lead management products. Read More
This is a very exciting time for med-tech in Europe despite companies facing regulatory and funding challenges, Todd Brinton, corporate vice president, advanced technology, and chief scientific officer at Edwards Lifesciences Corp. told BioWorld. Read More
The U.S. FDA’s draft guidance for predetermined change control protocols (PCCPs) is out for comment, but a recent agency webinar highlighted some areas of ambiguity. Read More
The U.S. FDA reported Sept. 17 that the Zimmer Biomet Holdings Inc. CPT hip system is associated with an increased risk of thighbone fracture, a problem Zimmer acknowledged with a July 2, 2024, class II recall. Read More
New hires and promotions in the med-tech industry, including: Adhere Health, Axosim, Biodura-Sundia, Blue Wind Medical, Nautilus Biotechnology, Novostia, Tiny Health. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Andor Health, Beckman Coulter, Boston Scientific, Endomimetics, Medisol, Palantir, Philip Morris, Phillips Medisize, Mindpeak, Molex, Respiree, Revvio, Roche, Safe Life, Scopio, Silk Road, Vectura, Vectura Fertin. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aifred, Boston Scientific, Epitomee, Philips, Piccolo, See-Mode. Read More
