FDA TEMPO pilot lets generative AI medical devices reach patients pre-authorization

The FDA has accepted four generative AI medical devices, including from Cadence and Limbic, into its TEMPO pilot, which permits digital health companies to market products without prior marketing authorization. This marks a regulatory shift toward post-market surveillance for AI-based tools, though the long-term safety and efficacy implications remain uncertain. The move could accelerate patient access to AI-driven care but raises questions about oversight.