FDA Updates AI & ML Med Device List

On Aug. 7, the FDA updated the list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. With this update, the FDA has authorized 950 AI/ML-enabled medical devices. 

 

The devices in this list 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.