As the Food and Drug Administration wrestles with how to regulate medical devices that rely on generative artificial intelligence to make decisions about care, it’s provisionally allowing some developers to launch their products on the market.
AI products from Cadence and Limbic are among four devices recently accepted into the agency’s TEMPO pilot program that will allow digital health companies to release their products without marketing authorization.
The pilot is intended to beef up the number of technologies available for the Medicare ACCESS model, an experiment in paying for technology to help beneficiaries manage chronic conditions. But it also offers the agency and companies the opportunity to experiment with AI regulation in the real world.