STAT Plus: Q&A: The FDA’s digital health chief on how to regulate futuristic AI products
SILVER SPRING, Md. — The Food and Drug Administration has allowed medical devices that rely on artificial intelligence algorithms onto the market, but so far, the agency has given the green light only to devices with “locked algorithms” — those that remain the same as the product is used until they’re updated by the manufacturer.
Systems with algorithms that evolve and sharpen on their own, however, are already in development.
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