{"id":352937,"date":"2025-12-16T22:49:16","date_gmt":"2025-12-16T22:49:16","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/352937\/"},"modified":"2025-12-16T22:49:16","modified_gmt":"2025-12-16T22:49:16","slug":"key-digital-and-device-leaders-depart-fda","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/352937\/","title":{"rendered":"Key digital and device leaders depart FDA"},"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

You\u2019re reading the web edition of STAT\u2019s Health Tech newsletter, our guide to how technology is transforming the life sciences.\u00a0Sign up to get it<\/a>\u00a0delivered in your inbox every Tuesday and Thursday.<\/p>\n

A tumultuous year at the Food and Drug Administration will be capped off at the agency\u2019s devices center with the departure of two key leaders, just as regulators are sorting through challenges related to artificial intelligence and launching new initiatives on software as a medical device regulation.\u00a0<\/p>\n

Sources tell us Jessica Paulsen, a 15-year veteran of FDA and acting deputy director of its Digital Health Center of Excellence is leaving the agency. She\u2019s been leading the center since last summer when the last acting head, SonjaFulmer, left FDA for Mayo Clinic. Fulmer took over for Troy Tazbaz who left in January to return to Oracle. The center\u2019s work includes communicating\u00a0with industry and developing\u00a0guidances relevant to digital health. (FDA did not respond to a request for comment.)<\/p>\n

Neuralink, Elon Musk\u2019s frothy brain-computer interface company, poached<\/a> David McMullen, director of FDA\u2019s office of neurological and physical medicine devices, which is in charge of regulating Neuralink. McMullen spent three years atop the office and previously worked at the National Institute for Mental Health.<\/p>\n

\"ScreenshotDavid McMullen, director of FDA\u2019s Office of Neurological and Physical Medicine Devices, and Jessica Paulsen, acting deputy director of the agency\u2019s Digital Health Center of Excellence. <\/p>\n

Both Paulsen and McMullen were at the forefront of important conversations about the future of regulation. I grabbed the screenshot above of the two leaders from a video of last month\u2019s Digital Health Advisory Committee meeting on generative AI-enabled mental health devices<\/a>. Separately, McMullen\u2019s office will have oversight of behavioral health devices under the FDA\u2019s new TEMPO<\/a> pilot.<\/p>\n

New to me: As part of the funding package that reopened the government last month, lawmakers passed full-year 2026 funding for FDA. Buried within the Senate report<\/a> accompanying the legislation, lawmakers direct FDA to, within 90 days, (February) report on its authorities to regulate AI medical devices, and\u00a0within 180 days, (May) report on \u201cthe status of the\u00a0 FDA\u2019s efforts regarding engagement on AI in drug development.\u201d\u00a0<\/p>\n

The Government Accountability Office last week released a report<\/a> on medical device recalls which found, among other things, that \u201cinsufficient staff limit FDA\u2019s ability to conduct oversight activities.\u201d In other words, the FDA already does not have enough staff to oversee medical devices and is losing key leadership at a time when new technology and initiatives may require additional horsepower.<\/p>\n

The future of the mammogram<\/p>\n

Applying AI to mammograms to help radiologists spot signs of breast cancer is increasingly common but researchers and AI companies want to apply\u00a0new analyses to\u00a0the routine screening tests to trigger more proactive care to prevent future cancers, heart attacks, and strokes. In one important breakthrough, the startup Clairity received FDA authorization for AI that offer a prediction of somone\u2019s five-year breast cancer risk based on a mammogram alone.<\/p>\n

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