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- FDA device center outlines FY 2027 guidance plan, targeting AI-enabled devices and change-control plansOn Oct 1, the FDA’s Center for Devices and Radiological Health announced its guidance agenda for fiscal year 2027. The top priority is finalizing guidance for artificial intelligence-enabled medic…
- FDA approves first pediatric heart valve that expands as children growThe U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…