FDA launches TEMPO pilot to let generative AI medical devices reach patients before formal approval

The Food and Drug Administration has opened a new pilot program called TEMPO that permits certain generative‑AI medical devices to be made available to patients even though they have not received full marketing authorization.

Four digital‑health products, including offerings from Cadence and Limbic, have been accepted into the pilot. The participants will be monitored as they operate in real‑world settings, giving regulators direct experience with the technology.

The initiative also supports the Medicare ACCESS model, an experiment that pays for technologies helping beneficiaries manage chronic illnesses. By allowing early market entry, the FDA hopes to gather data that can shape future rules for AI‑driven medical devices.