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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

UpDoc Says Its FDA-Cleared Insulin Software Is First With Patient-Facing LLMs

The 510(k)-cleared software lets adults with type 2 diabetes log data by voice or chat and receive insulin instructions computed from a treatment plan their clinician sets.

By News DeskJune 26, 20262 min read
A disposable insulin pen photographed against a white background.
An insulin pen on a white background. Not an UpDoc product; UpDoc is software that provides insulin instructions. Wesalius, CC BY 4.0, via Wikimedia Commons · CC BY 4.0
FDA cleared510(k) · K253281FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • UpDoc announced on June 25, 2026, FDA clearance for what it called the first software as a medical device that uses patient-facing large language models.
  • The FDA's 510(k) database lists UpDoc as K253281, decided December 23, 2025, in the drug dose calculator category, with a predetermined change control plan authorized.
  • The company said it has raised $18 million in seed financing and is in initial deployments at Cleveland Clinic, Allegheny Health Network and UCSF Health.

UpDoc, a Palo Alto, Calif., clinical AI company, said on June 25 that it has FDA clearance for the first software as a medical device that uses patient-facing large language models, a claim made in the company's release, read via investor Cathay Innovation. The software gives adults with type 2 diabetes insulin instructions based on a treatment plan set by their health care provider.

The clearance itself dates from December. The FDA's 510(k) database lists UpDoc under number K253281, received on September 29, 2025, and found substantially equivalent on December 23, 2025. The agency classifies it as a drug dose calculator, product code NDC, and the record shows a predetermined change control plan was authorized. A company representative confirmed to Medical Design and Outsourcing that the December clearance covers the product being launched.

What the cleared software does

According to the 510(k) filing as quoted by Medical Design and Outsourcing, UpDoc is a prescription-only product intended to provide medication management for patients 18 and older diagnosed with type 2 diabetes. Patients use a mobile app to log blood glucose, meals, symptoms and medication adherence, manually, by voice or text, or through a Bluetooth glucometer or continuous glucose monitor. Clinicians use a web portal to set insulin type, starting and maximum doses, the adjustment algorithm, blood glucose targets and safety protocols.

Insulin instructions are computed in UpDoc's cloud-based application from the parameters the clinician defines, the filing says. It also says the software does not interpret or diagnose symptoms; symptoms not covered by the treatment protocol trigger a system lock and an instruction to seek medical attention. The predicate device was the d-Nav Insulin Management Program, and the filing says no clinical testing was performed, Medical Design and Outsourcing reported.

Company plans and funding

UpDoc said its broader platform is meant to let clinicians deploy AI agents integrated with electronic health records that act between visits, for example by adjusting insulin within physician-approved parameters, ordering a follow-up test and documenting the change. The company described the product as designed to support doctors, not replace them.

"This FDA clearance marks a historic milestone for the field and the beginning of a new era in clinical care, where clinicians will be able to deploy clinical AI agents to help complete tasks autonomously on their behalf, much like engineers deploy coding agents today," said Sharif Vakili, UpDoc's chief executive.

The company said it has raised $18 million in seed financing to date from investors including the American Diabetes Association, Cathay Innovation, Eli Lilly and Company and Mayo Clinic. It said the platform followed a clinical trial its founders led at Stanford Medicine and is in initial deployment at Cleveland Clinic, Allegheny Health Network and UCSF Health. UpDoc did not publish results from that trial in the announcement.

Sources

  1. UpDoc Debuts First FDA-Cleared Clinical AI Platform Built for Real-Time Patient Care Delivery and Intelligent Care Coordination (company release, read via Cathay Innovation), Cathay Innovation (UpDoc release), June 25, 2026
  2. 510(k) Premarket Notification K253281: UpDoc, U.S. Food and Drug Administration, December 23, 2025
  3. What's UpDoc? The SaMD developer says it's the first FDA-cleared clinical AI platform, Medical Design and Outsourcing, June 26, 2026