Devices
FDA has issued Olympus a 10/7 Warning Letter based on GMP issues raised during inspections of the firm’s facilities in the U.S., Japan, and Europe conducted in late 2025. The items in the Warning Letter primarily concern “aspects of the company’s quality management system and related
Devices
FDA has updated a BD and CareFusion removal (Class 1 recall) of certain BD Alaris Pump infusion sets after additional testing found some sets can perform significantly worse than previously disclosed, potentially causing under- or over-infusion, delayed occlusion alarms and inaccurate bolus doses. The Alaris system is used for
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
Devices
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
Devices
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
Devices
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
Devices
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
Devices
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has found gaps in FDA's oversight of third-party organizations that review 510(k) medical device submissions, including outdated audit policies and a lack of deadlines for completing audits and communicating deficiencies to participating organizations.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
Devices
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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