FDA updates its list of AI, machine learning-enabled medical devices

The U.S. Food and Drug Administration (FDA) has updated its list of AI/machine learning-enabled medical devices.

The list now includes 950 of these devices, according to the agency. It is compiled from publicly available FDA summaries and AI/machine learning-specific product codes, as well as information in the FDA's publicly available resources and in materials published by manufacturers.

"[These] 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," the agency said.