{"id":498348,"date":"2026-03-01T23:58:37","date_gmt":"2026-03-01T23:58:37","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/498348\/"},"modified":"2026-03-01T23:58:37","modified_gmt":"2026-03-01T23:58:37","slug":"petition-pushes-fda-to-exempt-ai-devices-from-premarket-review","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/498348\/","title":{"rendered":"Petition pushes FDA to exempt AI devices from premarket review"},"content":{"rendered":"

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\u2019s promise. He\u2019s also the co-author of the free, twice weekly STAT Health Tech newsletter<\/a>. You can reach Mario on Signal at mariojoze.13.<\/p>\n

Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy \u2014 with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can reach Katie on Signal at palmer.01.<\/p>\n

The Trump administration has promised to reduce the barriers between health\u00a0artificial 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.<\/p>\n

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\u2019s performance.\u00a0<\/p>\n

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\u2019s proposal by mid-April, it will go into effect. At the same time it\u2019s considering the petition, the FDA announced that it had appointed a former senior executive<\/a> from a Harrison.ai subsidiary to direct the office that informs agency policy on AI.<\/p>\n

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