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- FDA releases discussion paper seeking input on regulation of generative AI medical devicesThe U.S. Food and Drug Administration issued a discussion paper outlining considerations for regulating generative AI-enabled medical devices and asked stakeholders to provide feedback. The paper…
- 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…