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A Pathway for Clinical AI Developers Opens: FDA Clears First Software as a Medical Device With Patient-Facing LLM

By Samuel C. Bernstein, Allyson M. Maur & Natalie Oehlers on July 6, 2026

On June 25, 2026, UpDoc Inc., a clinical AI company, announced that it received clearance from FDA for what the company describes as the first Software as a Medical Device (SaMD) that uses patient-facing large language models (LLMs). UpDoc describes its platform as an enterprise-ready agentic clinical AI platform designed to enable clinicians to deploy AI agents that are integrated with a provider’s electronic health record and other workflows to perform certain care-related tasks.

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  • Posted in:
    Corporate & Commercial
  • Blog:
    One-Stop Shop
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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