The U.S. FDA’s draft guidance for predetermined change control protocols (PCCPs) is out for comment, but a recent agency webinar highlighted some areas of ambiguity.
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.
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.
New hires and promotions in the med-tech industry, including: Adhere Health, Axosim, Biodura-Sundia, Blue Wind Medical, Nautilus Biotechnology, Novostia, Tiny Health.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aifred, Boston Scientific, Epitomee, Philips, Piccolo, See-Mode.
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
Days ahead of its contentious annual shareholders’ meeting slated for Sept. 19, Masimo Corp. established partnerships with two big players – Google LLC and Qualcomm Technologies Inc. – to significantly expand and support the ecosystem for Wear OS smartwatches by developing a next-generation smartwatch reference platform for original equipment manufacturers.
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