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.
Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.
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