Devices
An FDA advisory committee voted Wednesday to recommend approval of Grail's Galleri multi-cancer early detection blood test, voting unanimously, 10-0, that the test is safe, 6-4 that it is effective, and 7-2, with one abstention, that its benefits outweigh its risks for screening adults
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A 12/1-12/11/2025 FDA inspection at Specialty Health Products in Phoenix, AZ, found multiple violations in the firm’s illegal manufacturing of colonic irrigation systems and speculum kits. A just-released 7/7 Warning Letter lists these Quality System Regulation violations: * failure to establish and maintain design
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A machine learning-based approach to FDA's 510(k) medical device clearance process could reduce device recalls by nearly one-third while cutting the agency's regulatory workload by more than 40%, according to a study published in Management Science. The study evaluated a proposed system that
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A citizen petition is seeking a comprehensive safety investigation and potential recall of Intuitive Surgical's da Vinci Permanent Cautery Spatula, citing reports of mechanical and electrical component failures and a recent recall involving a related robotic surgical instrument. In the 9/20 petition , Jennifer Nelson, a patient who
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FDA has classified as Class 1 a CooperSurgical recall of certain INCA Infant Nasal CPAP Complete Sets and Neonatal Nasal CPAP Replacement Sets due to a loose tubing connection that could result in loss of respiratory support and decreased oxygenation in newborns and infants. The recall involves specific lots of
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A new Government Accountability Office (GAO) report has found gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, including outdated audit policies and a lack of deadlines for completing audits and communicating deficiencies to participating organizations. The 9/21 GAO report recommends
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FDA is seeking advisory committee input on 9/23 on the benefits and risks of GRAIL's Galleri multi-cancer early detection test after two pivotal studies showed that the blood-based screening test detected about one-third of cancers diagnosed within 12 months of testing. In an executive
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