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After Elsa, FDA rolls out 'agentic AI' for staff

December 2, 2025
avatar-mario-a
Health Tech Correspondent

Good morning health tech readers!

I spent a lovely long weekend with family in Connecticut, how about you? I only just got back to New York, and I'm off again into New England, this time on business. More on that another time...

I know Cyber Monday has finally passed us by, but I'm here to pitch you one more deal that is simply too good to pass up: Six months of STAT+ for $20. Only 20 bucks! Join us!

Reach me: mario.aguilar@statnews.com

startups

AI startup gobbled up by radiology giant

The tech arm of Radiology Partners, which reads more than 55 million images every year, recently acquired Cognita Imaging for $80 million. Founded by Stanford researchers, the startup is one of several that hopes to train vision-language models that can look at an X-ray or CT scan and identify any finding that looks important, rather than hunting for a specific abnormality.

Katie Palmer spoke to co-founder and CEO Louis Blankemeier about what makes Cognita different from the glut of AI startups clamoring for attention and the company's views on regulatory challenges for generative AI. 

Read the whole interview here


artificial intelliegence

FDA now offers 'agentic AI' tools to staff

The FDA announced it will continue its speedy push into the AI unknown with new "agentic AI capabilities" to support a range of regulatory work including pre-market reviews, review validation, post-market surveillance, inspections, and compliance. An agency spokesman told me that all regulatory decisions will ultimately be in the hands of staff. 

You may remember that the FDA, earlier this year, launched Elsa, an LLM-based tool to support agency staff. Early users reported the errors and fabulations that come along with LLM-based tech. FDA now claims over 70% of staff have used the product. 

Read my whole story on FDA's agentic push here

Do you have any experience with FDA AI? Don't hesitate to get in touch. Reach me confidentially at mariojoze.13 on Signal.


mental health

First wave therapy apps reckon with chatbot world

People are increasingly leaning on chatbots for emotional support, spurring legacy digital health apps to craft their own therapeutic bots in response, STAT's Rose Broderick reports.

So, what are they doing? Lyra Health, Talkspace, and SonderMind have built or are developing chatbots. Lyra, in particular, is piloting a product that is not designed to treat mental illness but instead "everyday challenges" like sleep or burnout. We also hear perspectives from Headspace, Calm, Spring Health, and more. Find out who's already thinking about ways to monetize the new tech and who thinks the benefits of LLM-powered bots might not be worth the risks. 

Read more here 



Health tech news roundup

  • OpenAI faces multiple lawsuits that claim that ChatGPT allegedly played a role in driving people to delusions and suicide. The company says it's working to make its models safer and in the spirit of that effort it's funding new research grants exploring AI and mental health totaling up to $2 million. 
  • Remember how Best Buy bought Current Health during the pandemic only to sell the company back to its co-founder earlier this year? Well, in its quarterly earnings release last week, BBY reported a $192 million impairment related to Best Buy Health. Ouchie. (H/T HISTalk for spotting.)
  • Lots of people are talking about the CMS innovation center's new ACCESS model that will incentivize providers to improve a patient's chronic disease. Under the experimental 10-year model launching in 2026, participating providers will receive recurring payments for managing conditions with "full payment tied to achieving measurable health outcomes." Specifically, regulators theorize that the new payment option will enable clinicians "to offer innovative technology-supported care that improves patients' health and complements traditional care." Coincidentally (or maybe not), the new model comes amid growing debate about Medicare reimbursement for remote patient monitoring services that are intended to deliver exactly these kinds of clinical outcomes by paying clinicians to keep tabs on their patients with devices like blood pressure cuffs. UnitedHealthcare just indicated it will stop paying for a bulk of these services next year because it doesn't believe the evidence supports unlimited coverage.
  • After Medicare payment for hospital at home programs lapsed for over a month during the government shutdown, the House of Representatives passed a bill that would extend the program through 2030. The very same day, Axios reported that hospital at home startup Inbound Health shut down. The company had raised over $50 million to date.

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What we're reading

  • Three years on, ChatGPT still isn't what it was cracked up to be – and it probably never will be, Marcus on AI
  • Silicon Valley's man in the White House is benefiting himself and his friends, New York Times
  • Informed consent: The opportunity for digital technology and artificial intelligence, Rob Califf

Thanks for reading! More next time - Mario

Mario Aguilar covers how technology is transforming health care. He is based in New York.


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