'UpDoc 1st FDA-Cleared AI Platform for Real-Time Patient Care, Intelligent Care Coordination'

 UpDoc, an enterprise-ready clinical AI company developing physician-grade agentic AI, today announced FDA clearance for the first Software as a Medical Device (SaMD) that uses patient-facing large language models. Combined with initial deployments at four of the nation's leading health systems, the company redefines and advances a rapidly emerging category of healthcare delivery – clinical AI – defined as AI that delivers care that historically required a licensed clinician. At a time when "AI doctors" are racing to market with limited scrutiny, UpDoc arrives as the first FDA-cleared agentic clinical AI platform designed to support doctors, not replace them. 

"We fundamentally believe that clinical AI should be held to the highest standard," said Sharif Vakili, MD, MBA, MS, CEO of UpDoc. "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. This breakthrough also has the potential to make primary care viable again by directly addressing some of the healthcare system's most pressing challenges: patient access, rising system costs and clinician burnout."

Updoc has secured $18 million in oversubscribed seed financing to-date from leading healthcare investors and strategic partners, including the American Diabetes Association, Cathay Innovation, Eli Lilly and Company, Mayo Clinic, Oxeon, Pear VC, Polaris Partners and Section 32. This financing will accelerate UpDoc's efforts to safely and responsibly scale clinical AI across provider settings with traceable accountability. 

UpDoc's platform moves beyond traditional administrative AI use cases – such as outreach, scheduling and billing inquiries – to help health systems scale more proactive, personalized care that would historically require an encounter with a physician or other licensed provider.  With UpDoc, licensed clinicians for the first time can deploy AI agents that are FDA-cleared and integrated with a provider's electronic health record (EHR). As a result, AI agents are able to extend clinical reach in between scheduled visits, delivering care side by side as an integral member of the care team (click here to see how Updoc works).

Unlike consumer-facing AI assistants or generalized applications built on top of foundation models, UpDoc was purpose-built as a clinical operating system embedded directly into provider workflows. At the core of the platform is UpDoc Clinical Intelligence, a proprietary orchestration and safety architecture that unifies clinical guidelines, longitudinal patient context, physician governance and EHR data to coordinate and execute real-world clinical care safely – at scale. The platform automates interventions that traditionally required a physician's direct, hands-on involvement with tasks such as adjusting medications, facilitating lab orders, coordinating with care teams and more. 

For example, consider a patient with Type 2 diabetes whose blood glucose has been drifting out of range. UpDoc's platform identifies the trend, initiates a titration of the patient's insulin regimen within physician-approved parameters, triggers the appropriate follow up test to confirm safety, and documents the entire intervention in the EHR – without the patient ever needing to schedule an appointment.

UpDoc's clinical AI platform represents a category-defining shift in healthcare delivery, enabling patients to access the kind of continuous, high-touch care once reserved for concierge medicine. At the same time, it empowers health systems to manage patients proactively between visits rather than waiting for the next appointment. The result is unprecedented access to care, deeper population health visibility, new revenue growth and reduced workforce strain.

UpDoc brings together an accomplished team of practicing physicians, engineers and leaders across healthcare and AI who understand the complex nature of today's healthcare system and the importance of seamless integration into existing clinical workflows, EHR environments and compliance frameworks.

UpDoc's clinical AI platform follows a landmark clinical trial led by its founders at Stanford Medicine and is undergoing initial deployment at premier healthcare systems, including Cleveland Clinic, Allegheny Health Network (AHN) and UCSF Health, with plans for broader expansion underway.

https://www.prnewswire.com/news-releases/updoc-debuts-first-fda-cleared-clinical-ai-platform-built-for-real-time-patient-care-delivery-and-intelligent-care-coordination-302810065.html