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- FDA issues draft guidance for generative AI medical devices as industry calls for German drug pricing reformThe U.S. Food and Drug Administration has published a draft guidance document that outlines the agency's expectations for medical devices that incorporate generative artificial intelligence. The dr…
- BD advises recall of sodium chloride ampules in convenience kits after Huons Co. issueThe FDA issued an Early Alert after Becton Dickinson (BD) sent a letter to customers about a potential high‑risk device issue. The alert concerns convenience kits and procedural trays that contain…