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

TEMPO program offers regulators hands-on experience with cutting edge tech in real-world settings Adobe Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13. 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. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. Already have an account? Log in View All Plans To read the rest of this story subscribe to STAT+. Subscribe Health Tech Correspondent Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.