STAT+: A provocative proposal asks the FDA to let some AI devices on the market without review

STAT News · Feb 23, 2026 · Collected from RSS

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Petition would shift the burden of evidence to post-market monitoring for six product types Adobe Mario Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech’s promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can reach Katie on Signal at palmer.01. The Trump administration has promised to reduce the barriers between health artificial intelligence developers and patients. With a provocative new proposal, an AI company has offered regulators a way to let a broad swath of potentially risky AI devices flood the market. AI developer Harrison.ai last October petitioned the Food and Drug Administration to allow manufacturers to release certain new AI products radiologists use to analyze medical images without review, provided the FDA has previously cleared a relevant product from a company. AI developers would also need to follow certain technical standards and offer a plan for how to keep tabs on the product’s performance. The FDA allows anyone to submit a petition asking for devices to be exempted from review, but it happens rarely. The agency must respond within 180 days, and if it does not deny Harrison.ai’s proposal by mid-April, it will go into effect. At the same time it’s considering the petition, the FDA announced that it had appointed a former senior executive from a Harrison.ai subsidiary to direct the office that informs agency policy on AI. 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 Aguilar covers technology in health care, including artificial intelligence, virtual reality, wearable devices, telehealth, and digital therapeutics. His stories explore how tech is changing the practice of health care and the business and policy challenges to realizing tech’s promise. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13. Health Tech Correspondent Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can reach Katie on Signal at palmer.01.