Breaking News

Europe certified a medical LLM tool — what about FDA?

July 8, 2025
Health Tech Correspondent

Good morning health tech readers!

Hope everyone had a restful holiday!  Today, a look at the LLM product certified in Europe. Plus: Some takes on recent investment.

Reach me: mario.aguilar@statnews.com

Artificial Intelligence

Details about that LLM device certified in Europe

In March, a large language model-based tool was certified in Europe as a class IIb medical device. But would it have passed muster with the Food and Drug Administration?

The product, called "Prof. Valmed," uses GPT-4o to come up with diagnosis and treatment suggestions for physicians based on its library of guidelines and documents. But its website has an unusual disclaimer for a medical device: Prof. Valmed does not take any responsibility for the accuracy of its medical advice.

Read more from Brittany Trang about the questions Prof. Valmed raises for the FDA and the medical AI industry at large. 


personnel file

Apple hires from AI mental health startup

ICYMI, I published an in-depth look at the shut down of Woebot, a therapy chatbot app, as the developer, Woebot Health pivots to a new path. As part of the change in direction, Woebot is down to nine employees from a peak of 120.

I spotted two former senior employees from Woebot that have started jobs at Apple in recent months, according to their LinkedIn profiles:

  • Athena Robinson was chief clinical officer at Woebot from 2017 until February where she helped lead the company's research and clinical trials efforts. Her LinkedIn now says that she works on "Health @ Apple."
  • Tim Campellone, was vice president, translational research at Woebot, also until February. Now he's working on health products at Apple. He was the first author on Woebot Health's recent publication describing a study where the company compared the original version of its chatbot to one that used some generative AI elements.

While I have no idea what Robinson and Campellone are working on at Apple — they are not allowed to talk to the media — here's a little interesting context around the hires:

  • Apple has been publicly making inroads on mental health for a few years. In 2023, the company added features that allow users to log their moods and take common mental health assessments for anxiety and depression. Among the relationships Apple hinted it was interested in exploring in the large new health study it launched earlier this year is "mental health's impact on heart rate."
  • Apple is also reported to be working on an AI health coach. Perhaps experience working with a friendly chatbot meant to help people open up about their emotions could be relevant to this project.

It's not just Apple. Mental health tech company Headspace also hired a former Woeboteer: Ellis Bernstein, a former senior AI translational scientist at the company, is now an AI clinical product specialist at Headspace, which last year introduced a chatbot feature.



INvestment

Will recent IPOs help digital health funding?

02_H1-2025_AI-Funding-Graphic-vF-1024x576

Digital health startups raised $6.4 billion dollars in the first half of 2025, a modest increase from the the same period a year before, according to an analysis from Rock Health. AI-enabled startups accounted for 62% of the funding; the money overall was raised across fewer deals; and there have already been 11 "mega deals" over $100 million — we saw 17 all of last year. (Two of those mega deals were for AI scribe company Abridge.)

The Rock Health authors go on to make the case that though the top line investment number didn't move much from recent years, the first half gave us proof points illustrating the potential of digital health. First, we saw Hinge Health and Omada go public, illustrating that "tech-enabled services companies are realizing transformed, sustainable care delivery." And second, the speedy adoption of well-funded AI use cases like AI scribes "show that breakout growth is possible with the right mix of provider trust, intuitive and impactful products, and capital to scale."

Will these proof points help drive a big second half of the year? We'll see.


Julie Yoo from a16z on "challengers" and "enablers"

Screenshot 2025-07-08 at 6.38.19 AM

Andreessen Horowitz general partner Julie Yoo analyzed nearly 3,800 health tech VC deals from 2010 to 2024 and found a recent relative increase in funding for "full stack" companies that have cropped up to challenge incumbent players. These challengers, or "insurance companies, medical services companies, pharmacies," are contrasted to "enablers," like startups working on AI automation and revenue cycle management. From 2010 to 2014 enablers raised more than double the capital compared to challengers. From 2020 to 2024, it was just 10% more. Over the last 15 years, "Enablers have dominated in terms of overall volume of deals, but the ratio of VC deals into Challengers versus Enablers has risen," Yoo writes. 

The analysis draws on a similar dynamic from the venture-backed tech industry where both challengers like Airbnb and Uber and enablers like Stripe and Databricks were needed to prop up the transformation we've seen today. Yoo's whole post goes much deeper on the two kinds of startups and also offers a link to the raw data.


More around STAT
Check out more exclusive coverage with a STAT+ subscription
Read premium in-depth biotech, pharma, policy, and life science coverage and analysis with all of our STAT+ articles.

What we're reading

  • Inside the staff exodus and tanking morale that threaten Makary's FDA, STAT
  •  Aktiia gets FDA clearance for OTC cuffless blood pressure monitor, Mobihealthnews

Thanks for reading! More next time - Mario

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


Enjoying STAT Health Tech? Tell us about your experience
Continue reading the latest health & science news with the STAT app
Download on the App Store or get it on Google Play
STAT
STAT, 1 Exchange Place, Boston, MA
©2025, All Rights Reserved.

No comments