{"slug": "stat-fda-pilot-offers-generative-ai-medical-devices-a-path-to-patients-before", "title": "STAT+: FDA pilot offers generative AI medical devices a path to patients before they are authorized", "summary": "The U.S. Food and Drug Administration (FDA) has provisionally accepted four generative AI medical devices, including products from Cadence and Limbic, into its TEMPO pilot program, allowing them to reach patients before receiving full marketing authorization. The pilot aims to expand technologies available under the Medicare ACCESS model, which tests payment for chronic condition management tools, while letting the FDA and companies experiment with AI regulation in real-world settings.", "body_md": "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.\n\nAI 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.\n\nThe 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.\n\n## This article is exclusive to STAT+ subscribers\n\n### Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.\n\nAlready have an account? [Log in](/login/)\n\n[View All Plans](https://www.statnews.com/stat-plus/)", "url": "https://wpnews.pro/news/stat-fda-pilot-offers-generative-ai-medical-devices-a-path-to-patients-before", "canonical_source": "https://www.statnews.com/2026/09/03/tempo-fda-pilor-generative-ai-medical-device-regulation/?utm_campaign=rss", "published_at": "2026-09-03 08:30:00+00:00", "updated_at": "2026-09-03 08:54:44.385597+00:00", "lang": "en", "topics": ["artificial-intelligence", "ai-policy", "ai-products"], "entities": ["Food and Drug Administration", "Cadence", "Limbic", "Medicare ACCESS model", "TEMPO pilot program"], "alternates": {"html": "https://wpnews.pro/news/stat-fda-pilot-offers-generative-ai-medical-devices-a-path-to-patients-before", "markdown": "https://wpnews.pro/news/stat-fda-pilot-offers-generative-ai-medical-devices-a-path-to-patients-before.md", "text": "https://wpnews.pro/news/stat-fda-pilot-offers-generative-ai-medical-devices-a-path-to-patients-before.txt", "jsonld": "https://wpnews.pro/news/stat-fda-pilot-offers-generative-ai-medical-devices-a-path-to-patients-before.jsonld"}}