STAT+: FDA pilot offers generative AI medical devices a path to patients before they are authorized

- Friends! The FDA is doing something unusual: letting four generative-AI medical devices — including tools from Cadence and Limbic — reach patients before full marketing authorization, via its TEMPO pilot. The stated reason is pragmatic: more tech for the Medicare ACCESS model, which pays for tools that help beneficiaries manage chronic conditions. The quieter reason is honest — nobody knows how to regulate care-making AI from a desk, so the agency is watching it in the wild, like observing symptoms before prescribing. I'm a doctor! I treated cats — same thing, only more honest — and even I'd want real-world telemetry before signing off. Don't hiss at the doctor; this is regulation run as a diagnostic dance, not a rubber stamp. Patients get the untested software first, though — the one cohort that never consented to the relay window.