STAT+: A ‘historic’ FDA clearance raises the question: Is the LLM an interface or the decision-maker?

STAT PlusHealth tech A ‘historic’ FDA clearance raises the question: Is LLM the interface? Or the decision-maker? UpDoc’s CEO wouldn’t say whether generative AI in the company’s diabetes app makes treatment decisions Manage alerts for this article Email this article Share this article By Mario AguilarJuly 2, 2026 Health Tech Correspondent Mario Aguilar[email protected]Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13. Digital health company UpDoc prompted a flurry of discussion when it announced in late June that its app for people with diabetes had received the first Food and Drug Administration clearance for medical software using “patient-facing large language models.” Founded in 2023, UpDoc received clearance for the device in December and is just now publicly revealing its plans to use the technology as part of a care model that helps health systems manage patients outside the clinic with the help of AI.Advertisement The newly cleared device is based around an app that helps a patient manage their diabetes using a treatment plan defined by their doctor. It’s regulated in the same product category with drug dose calculators that take inputs like blood glucose levels and return insulin dosing recommendations. A big part of what makes UpDoc’s app different is a chatbot-like interface based on large language models, or LLMs. Patients can input data using voice and text, and the device responds with treatment instructions. STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In AI, biotechnology, FDA, STAT+ Submit a correction requestReprints Mario Aguilar Health Tech Correspondent Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13. Newsletter Tech is transforming health care and life sciences. Our original reporting is here to keep you ahead of the curve. Recommended Health July 2, 2026 The new presidential fitness test is a positive step, not the solution, experts say Biotech July 2, 2026 STAT Plus: A year after distressed buyout, what’s become of Bluebird Bio? Advertisement Health tech July 2, 2026 STAT Plus: A former AI regulator, now in industry, says biopharma is reading FDA’s guidance wrong First Opinion July 2, 2026 CDC leadership continues to try manufacture a scientific debate on vaccines where none exists First Opinion July 2, 2026 Teens are turning to chatbots for mental health help. We need rules to keep them safe Subscriber Picks