AdvaMed® - Advanced Medical Technology Association®10/27 19:01 UTC
AdvaMed Encourages Risk-Based FDA Approach to Generative AI Medical Devices
AdvaMed encouraged the U.S. Food and Drug Administration to build on its existing regulatory framework for generative AI-enabled medical devices rather than create new frameworks. The comments respond to an FDA discussion paper (Docket No. FDA-2026-N-7874) seeking early input on assessing risks and evaluating such devices before marketing and in post-market monitoring.
Read the original →Digital Health News10/28 10:32 UTC
Vera Health Raises $28.5 Mn in Series A Funding for Clinical AI Search Platform
Vera Health has raised $28.5 million in a Series A funding round led by Threshold Ventures, with participation from Optum Ventures, Mantis VC, and SV Angel. The company plans to use the funding to expand its evidence-based clinical AI search platform, strengthen its infrastructure, and support international growth.
Read the original →Law36010/28 02:57 UTC
OpenAI Sued Over Epilepsy Death Allegedly Tied To ChatGPT
The parents of a Chinese national with epilepsy who died earlier this year sued OpenAI on Tuesday in California state court. They allege ChatGPT was effectively practicing medicine without a license when it designed a tapering schedule for the anti-seizure medication that was keeping their daughter alive.
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