Becker's Healthcare May 15, 2024
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,...