Becker's Healthcare May 15, 2024
Claire Wallace

As of May 13, the FDA has cleared 882 AI/ML-enabled medical devices, including nine anesthesiology products.

The cleared devices have met the FDA’s applicable premarket requirements, including a focused review of the devices’ overall safety and effectiveness, which includes an evaluation of appropriate study diversity based on the device’s intended use and technological characteristics.

Note: The FDA’s list is not meant to be an exhaustive or comprehensive resource of medical devices that incorporate AI/ML. Rather,...

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