UpDoc just landed the first FDA clearance for a patient-facing AI model, which acts as a “concierge doctor” to support patients between visits. Good news for the human docs reading this – it isn’t going after your job just yet.
What’s UpDoc? It’s a clinical AI platform that unifies clinical guidelines, longitudinal patient context, and physician governance to safely execute real-world care.
What isn’t UpDoc? An AI doctor.
- The 510(k) clearance had a narrow scope. It allows the AI to call or message patients between visits and adjust their insulin doses within parameters set by human clinicians.
- UpDoc says its AI will ease doctors’ workloads and help patients better manage illnesses like Type 2 diabetes.
The data backs that up. A study in JAMA Network Open saw 32 patients with T2D randomized to receive support from UpDoc (daily voice AI checkins to record blood glucose and adjust insulin doses) or standard care (AKA log their own data until they see a doctor).
- The AI group hit their target blood glucose in 15 days on average, compared to the standard care group where fewer than half got there at all within 8 weeks.
- That trial was the clinical foundation for the recently-cleared solution, which is now set to be piloted at Cleveland Clinic, UCSF, and Allegheny Health Network.
UpDoc is taking the road less traveled. It’s not the only AI startup in this wheelhouse, but so far it’s one of the only ones that doesn’t seem to be actively avoiding FDA regulation.
- The most notable example is Doctronic, which has been testing its AI prescription tech through a state-run program in Utah rather than seeking a full-fledged authorization.
- That’s an easier path to market than vaulting over FDA hurdles, but it doesn’t get you the “world first” feather in your cap that now belongs to UpDoc.
So, now what? The FDA has long debated how to regulate AI, and UpDoc could be the first sign that they’re now comfortable enough with the tech to give the green light to more models.
- With the first clearance out of the way, other AI developers also have an established precedent and a blueprint to follow suit.
Don’t forget about the docs. Besides the regulatory shakeout, it’ll be equally interesting to see how this new breed of AI ends up in the hands of clinicians.
- We saw OpenEvidence fold a new biomarker for heart disease into its platform just last week, and the most direct path to a wide distribution for many soon-to-be-cleared AI tools could be similar licensing partnerships.
- Plenty of companies already have a massive user base and are actively expanding the clinical scope of their platforms – Abridge, OE, Doximity, the list goes on and on. It feels like licensing models from the UpDocs of the world is a natural next step after all the journal partnerships we’ve been seeing now that FDA clearance is part of the picture.
The Takeaway
The FDA finally cleared its first patient-facing clinical AI model, and UpDoc might have been the first domino, but it definitely won’t be the last.
