How AI is transforming radiology

Katie Palmer braved frigid temperatures in Chicago last week to learn about the hot, hot world of using artificial intelligence to analyze medical imaging at the Radiological Society of North America annual meeting. She's already delivered two brilliant readouts:

Radiology was an early adopter of AI technology but as researchers and startups forge ahead lean with a new wave of the technology, practices and are still scrambling to catch up with the older generation of tech. Read more here.
With the rise of large vision models that can perform broader interpretation of imaging like chest X-Rays, there's a growing debate about how much work should be offloaded to AI — especially given the shortage of radiologists. Read more here.

digital therapeutics

Schizophrenia DTx is headed to FDA

Speaking of frigid temperatures, last week I drove 60 terrifying, snowy miles on uncleared Vermont highway to attend a digital health summit at Dartmouth College's Center for Technology and Behavioral Health. On top of some very interesting perspectives on AI regulation throughout the day, the highlight was the first U.S. presentation of data from an RCT of an experimental digital therapeutic, CT-155, that treats negative symptoms of schizophrenia, including lack of motivation and the inability to feel pleasure.

Some of the topline data was released by developers Boehringer Ingelheim and Click Therapeutics in October. The DTx met its primary endpoint by meeting a pre-specified threshold for effect size on a rating scale for negative symptoms. But Boehringer's global brand head for prescription digital therapeutics offered some interesting details about the study design as well as an update on what's next: The company is preparing to submit the product to the Food and Drug Administration for clearance.

regulaton

FDA hopes to push TEMPO to improve ACCESS

The FDA in January will begin taking interest for a new pilot program, called TEMPO, that may allow developers of digital medical devices leeway to market their products without clearance under supervision from the agency. The agency will select "up to about 10" manufacturers for each of the four clinical areas targeted by the CMS innovation center's new ACCESS model: Early and late cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. The ACCESS model promises to pay providers for helping patients manage chronic conditions and improving outcomes instead of paying for the delivery of discrete services, like blood pressure monitoring.

There's more to unpack — and important unknown details — about both TEMPO and ACCESS, including how much ACCESS participants will be paid. As we wait for clarity, if you're developing a device and considering applying to the TEMPO program or want to share your thinking about why it doesn't make sense for you, I'd love to hear from you: mario.aguilar@statnews.com

Elsewhere, FDA updated its lists of authorized AI, virtual reality, and sensor-based medical devices. It's added 110 AI/ML devices since the last update.

Health tech news roundup

Hera, a startup that promises to help manage care for older people, came out of stealth with $7.2 million in seed funding led by Accel. The company has partnerships with large New York-based academic medical centers including NYU Langone Health, Weill Cornell Medicine, and Mount Sinai.
OpenEvidence launched a 'Dialer' that allows physicians to call patients with a caller ID of their choice, rather than their personal phone number. Yes, competitor Doximity offers a similar product with the exact same name.
The federal health department selected C3 as its enterprise AI platform to "integrate disease-specific NIH data enclaves with Medicare, Medicaid, claims, and state registry datasets."
Hims & Hers Health plans to acquire YourBio Health, a developer of blood sampling technology.

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