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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
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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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Tags: AI
Photo of Samuel C. Bernstein Samuel C. Bernstein

Sam focuses his practice on healthcare regulatory compliance, general corporate representation of healthcare providers and suppliers, contract negotiation, and transactional matters.

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Photo of Allyson M. Maur Allyson M. Maur

Allyson advises on regulatory issues affecting diagnostics developers, biopharma manufacturers, and clinical laboratories, including CLIA/CLEP and FDA regulatory advice, MLR and MRC review of marketing and promotional materials, clinical studies, global data privacy issues, ethics & compliance, commercial contracting, commercial litigation and more.

Read more about Allyson M. MaurEmail
Photo of Natalie Oehlers Natalie Oehlers

Natalie counsels clients on complex regulatory, transactional, and strategic matters across the healthcare and life sciences sectors, focusing on pharmaceuticals, medical devices, cosmetics, food products, dietary supplements, and cannabis-related products.

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  • Posted in:
    Health Care and Life Sciences, Technology and AI
  • Blog:
    One-Stop Shop
  • Organization:
    McGuireWoods LLP
  • Article: View Original Source

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