{"id":395021,"date":"2026-01-08T00:39:19","date_gmt":"2026-01-08T00:39:19","guid":{"rendered":"https:\/\/www.newsbeep.com\/ca\/395021\/"},"modified":"2026-01-08T00:39:19","modified_gmt":"2026-01-08T00:39:19","slug":"fda-relaxes-oversight-of-ai-enabled-devices-and-wearables","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/ca\/395021\/","title":{"rendered":"FDA relaxes oversight of AI-enabled devices and wearables"},"content":{"rendered":"

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\t\t\t\tFood and Drug Administration Commissioner Marty Makary.ANDREW CABALLERO-REYNOLDS\/AFP via Getty Images<\/p>\n

Lizzy Lawrence leads STAT\u2019s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.<\/p>\n

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

LAS VEGAS \u2014 The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration\u2019s promises to deregulate artificial intelligence and promote its widespread use.<\/p>\n

FDA Commissioner Marty Makary indicated that one of the agency\u2019s priorities is fostering an environment that\u2019s good for investors, and that FDA regulation needs to move \u201cat Silicon Valley speed.\u201d He announced the changes during an address to conference attendees at the Consumer Electronics Show.<\/p>\n

The agency will soften its approach<\/a> to the regulation of clinical decision support software, which include AI-enabled products that help doctors navigate diagnoses and treatment options. The agency previously considered products that delivered a single recommendation as FDA-regulated medical devices. Now, those products can enter the market without FDA review as long as they fulfill the agency\u2019s other criteria for escaping regulation.\u00a0<\/p>\n

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Lizzy Lawrence leads STAT\u2019s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53.<\/p>\n

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Health Tech Correspondent<\/p>\n

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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

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Health Tech Correspondent<\/p>\n

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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

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Brittany Trang, Ph.D., is a health tech reporter at STAT and writes the AI Prognosis newsletter<\/a>. Follow her on Threads<\/a>, Mastodon<\/a>, and Bluesky<\/a>. You can reach Brittany on Signal at btrang.01.<\/p>\n","protected":false},"excerpt":{"rendered":"Food and Drug Administration Commissioner Marty Makary.ANDREW CABALLERO-REYNOLDS\/AFP via Getty Images Lizzy Lawrence leads STAT\u2019s coverage of the…\n","protected":false},"author":2,"featured_media":395022,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[276,49,48,2714,84,27907,392,2101,9306],"class_list":{"0":"post-395021","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-artificial-intelligence","9":"tag-ca","10":"tag-canada","11":"tag-fda","12":"tag-health","13":"tag-health-tech","14":"tag-healthcare","15":"tag-stat","16":"tag-wearables"},"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/395021","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=395021"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/395021\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/395022"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=395021"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=395021"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=395021"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}