AI health guides say they don't replace doctors, but FDA calls diagnosis a medical device

YvesMulkers · x · 2026-10-24

A new AI health guide tells doctors "this tool does not replace you," but author Yves Mulkers argues the regulation disagrees the moment a tool touches diagnosis — the FDA classifies that as a medical device, full stop.

He poses the operational question to the industry: when your last clinical AI tool shipped, who signed off — you or compliance? A pointed take on the gap between marketing language and regulatory reality in clinical AI.

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AI health guides say they don't replace doctors, but FDA calls diagnosis a medical device

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