AI therapy app pulled in UK

Slingshot AI, maker of the therapy chatbot Ash, told users in the United Kingdom that the app will no longer be available, citing concerns it runs afoul of regulations.

There's healthy debate in the United States about which mental health apps and AI products are subject to Food and Drug Administration regulation. But in the U.K., there's little wiggle room for products that claim they aren't devices because they're intended for wellness purposes. I explain more in my story.

fundraising

OpenEvidence raises big, looks beyond ads

If it feels like we were just talking about OpenEvidence — we were. Just a week go, the maker of a popular chatbot for clinical evidence promised "medical superintelligence" at its first ever JPM presentation. Now it's announced $250 million in new funding, bringing its total announced over the last year to $735 million. The company is valued at $12 billion.

One begins to wonder how an advertising business model justifies that big number, and CEO Daniel Nadler told me that indeed the valuation is based on a more ambitious bet that AI that can "solve" medical cases "would have nearly infinite economic value to human civilization."

Radiology

FDA clears AI tool to detect 14 conditions

Aidoc, a well-funded radiology AI company, on Wednesday announced it received FDA clearance for a a tool that can triage 14 critical findings in a single abdominal CT scan: liver injury, spleen injury, bowel obstruction, appendicitis, and more.

As my colleague Katie Palmer reports, the new AI hints at a coming future. More developers are experimenting with large vision models that can be used to identify many different conditions from a single x-ray, MRI, or CT scan. This may require new regulatory approaches from FDA which right now evaluates indications one at a time.

While creating a single product that can scan for many conditions may simplify workflows for radiologists who must juggle a growing arsenal of technology at their disposal, it could also amplify risks, including that an AI will falsely identify signs of a condition a patient doesn't have.

policy

HHS brings back tech advisors minus their leaders

After halting meetings of the Health Information Technology Advisory Committee (HITAC) last year, President Trump's HHS is bringing it back for four meetings in 2026, beginning with one on February 19th. I learned that co-chairs Sarah DeSilvey and Medell Briggs-Malonson told the rest of the committee in early January that they would not return. Reached for comment, both deferred to the Assistant Secretary for Technology Policy. Notably, Briggs-Malonson recently ended her tenure at UCLA Health where she was chief of health equity.

The HITAC has traditionally conducted substantive work advising ONC/ASTP on health IT policies. A look back at the 2024 annual report highlights the group's work reviewing updates to EHR certification criteria and technical standards and recommending areas of focus. It will be interesting to watch if any work on the "design and use of technologies that advance health equity" continues.

Health tech news roundup

Amazon One Medical introduced a chatbot that can provide users with guidance based on medical records. It can help book appointments, explain lab results, and renew medications.

During a press call with reporters Wednesday, AdvaMed CEO Scott Whitaker said that securing coverage for devices deemed breakthroughs by FDA is a priority. Apart from efforts to pass legislation, Whitaker suggested CMS may issue a rule to enhance the existing temporary coverage available to breakthrough device manufacturers. Will it be a redux of MCIT, the repealed Trump 1.0 policy that guaranteed coverage for all FDA breakthroughs? We'll see. Katie wrote about this issue recently.
Longer-term extensions of pandemic era Medicare telehealth flexibilities and the acute hospital care at home waiver program made it into the health department funding package released by Congress this week. It also includes a proposal to cover multi-cancer screening tests. Of interest to health tech readers, one well-known test from maker Grail is offered by Function Health, the startup from Robert F. Kennedy Jr. ally Mark Hyman. Read more on the package from my colleagues here.
The Veterans Health Administration's use of generative AI chatbots in clinical care poses risks to patient safety according to a preliminary report released by the Office of Inspector General. VA GPT, an internally developed tool, and Microsoft 365 Copilot Chat are authorized for use with patient information. OIG found that the VHA's AI efforts are led by an informal collaboration between AI offices that "did not coordinate with National Center for Patient Safety in the fielding of AI chat tools for clinical use." OIG is concerned that VHA doesn't have a standard process for managing AI risk. (H/T to Nextgov for spotting.)
Zarminali Pediatrics raised a $110 million Series A round led by Healthier Capital with participation from General Catalyst and K2 HealthVentures. The funding will be used to expand the providers' technology platform, open new clinics, and expand beyond primary care.

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