The FDA's Regulatory Juggling Act: AI Devices, Stem Cell Crackdowns, and the Battle Over Foreign Data

The FDA just created a new fast lane for artificial intelligence in medicine. The agency's TEMPO pilot program now allows generative AI medical devices—including products from Cadence and Limbic—to reach patients before receiving full marketing authorization. This is the first time the FDA has let companies launch AI-driven care tools while still monitoring them in the real world. The program ties into Medicare's ACCESS model, which pays for technology that helps...