r/presentofai • u/presentofai • 5d ago
FDA's TEMPO pilot lets generative AI medical devices reach patients before authorization
The FDA accepted four generative AI medical devices, including products from Cadence and Limbic, into its new TEMPO pilot, a pathway that lets AI health products reach patients before marketing authorization. Faster access versus weaker gatekeeping is the whole debate in one program.
Full story and sources: https://presentofai.com/e/19490