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

As the FDA grapples with how to regulate medical devices that use generative AI to make care decisions, it is now provisionally allowing some developers to launch their products on the market. Among the first four devices accepted into the agency's TEMPO pilot program are AI products from Cadence and Limbic, which will be able to release their devices without marketing authorization.

The pilot is intended to increase the number of technologies available under the Medicare ACCESS model, an experiment that pays for technology to help beneficiaries manage chronic conditions. It also gives the FDA and companies the chance to experiment with AI regulation in real-world settings, providing the agency hands-on experience with cutting-edge technology outside traditional regulatory approval pathways.