LAS VEGAS — The Food and Drug Administration announced Tuesday that it will ease regulation of digital health products, following through on the Trump administration’s promises to deregulate artificial intelligence and promote its widespread use.

FDA Commissioner Marty Makary indicated that one of the agency’s priorities is fostering an environment that’s good for investors, and that FDA regulation needs to move “at Silicon Valley speed.” He announced the changes during an address to conference attendees at the Consumer Electronics Show.

The agency will soften its approach 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’s other criteria for escaping regulation. 

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A tumultuous year at the Food and Drug Administration will be capped off at the agency’s 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. 

• 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’s 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’s work includes communicating with industry and developing guidances relevant to digital health. (FDA did not respond to a request for comment.)
• Neuralink, Elon Musk’s frothy brain-computer interface company, poached David McMullen, director of FDA’s 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.

• 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’s Digital Health Advisory Committee meeting on generative AI-enabled mental health devices. Separately, McMullen’s office will have oversight of behavioral health devices under the FDA’s new TEMPO pilot.
• 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 accompanying the legislation, lawmakers direct FDA to, within 90 days, (February) report on its authorities to regulate AI medical devices, and within 180 days, (May) report on “the status of the  FDA’s efforts regarding engagement on AI in drug development.” 
• The Government Accountability Office last week released a report on medical device recalls which found, among other things, that “insufficient staff limit FDA’s ability to conduct oversight activities.” 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.

The future of the mammogram

Applying AI to mammograms to help radiologists spot signs of breast cancer is increasingly common but researchers and AI companies want to apply new analyses to the 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’s five-year breast cancer risk based on a mammogram alone.

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What to know about the FDA’s therapy bots meeting

The Food and Drug Administration is considering whether and how to regulate therapy chatbots that are based on large language models. Today, the agency’s Digital Health Advisory Committee is meeting to consider the topic. In a new story, I explain what’s going on, including some fresh insider intel.

The FDA wants to provide more clarity to developers of generative AI medical devices about what needs regulatory green light and how to get it. The agency is also also worried about LLM-based therapy bots that can provide unpredictable outputs. Regulators are aware about the growing concerns around general purpose bots like ChatGPT, which have been linked to delusions and allegedly to suicides.

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Abridge vs. OpenEvidence, round one

New announcements from Abridge and OpenEvidence,  two of the most prominent health tech startups to emerge in recent years, highlight how despite different initial offerings, many artificial intelligence companies in health care will just end up competing with each other for physician eyeballs.

On Monday morning, Abridge, best known for its AI scribe that helps doctors automate the writing of clinical notes, announced a new product that will surface “real-time insights, prompts, and pathways” from the widely-used medical resource UpToDate based on things said in a clinical conversation and that are written in the patient’s record. 

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Earlier this year, Tom Stanis was puzzling through what was next for his startup Story Health, which helps providers care for people with heart failure. The company had some big-name customers and plans to expand, but it last raised money in 2022. Stanis saw two options: shake more cash out of a stingy venture capital market, or sell.

Armed with $275 million in fresh funding and a built-in customer base, artificial intelligence company Innovaccer made the answer easy. It gobbled up Story Health for an undisclosed mix of equity and cash in September. 

Story Health is the fourth Innovaccer acquisition in about a year as it aims to become the default AI platform for health systems. CEO Abhinav Shashank plans to rapidly expand and to “accelerate that development through M&A,” he told STAT.

Innovaccer’s shopping spree is just one example of a trend playing out in digital health: big, well-funded companies with momentum are snapping up smaller players.

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Califf warns AI in health care ‘overhyped’

On a makeshift stage in a Midtown Manhattan office earlier this week,former Food and Drug Administration Commissioner Robert Califf struck a measured tone about the potential for artificial intelligence in health care. Asked whether the technology was overhyped he said it was. “I hear way too much about the money. I’m not hearing a lot of human values coming through discussions,” he said. Adding:

“Almost all of the technology is being applied to optimizing the financial status of healthcare delivery entities or companies that are making medical products and that’s not aligned with equitable, better patient outcomes. So until someone puts a soul back in the system, I think it’s going to get worse and worse.”

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