Samuel C. Bernstein

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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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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

Posted in Privacy, Product Labeling

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…

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Samuel C. Bernstein

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

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