AI developers battle with FDA, what’s next with Amazon and One Medical, & protecting wearables data

Stat News

23 February 2023 - Health tech companies are in a tizzy. After years of letting companies roll out software tools to guide patient care with little oversight, the FDA is taking a tougher stance.

In September, the FDA announced its intentions to regulate many of these AI powered clinical decision support tools as devices — which regulators say has always been their plan and within their purview. But the industry says it was blindsided by the move.

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Michael Wonder

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Michael Wonder