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, it is a list of medical devices that incorporate AI/ML across medical disciplines.
The nine anesthesiology AI/ML-enabled medical devices cleared by the FDA:
EnsoData’s Aurora
Tyto Care’s Tyto Insights for Wheeze Detection
Intelligent Ultrasound Limited’s ScanNav Anatomy Peripheral Nerve Block
Belun Technology Company Limited’s Belun Sleep System BLS-10
Medasense Biometrics’ PMD-200
NuvoAir AB’s Air Next
Zephyr Sleep Technologies’ MATRx Plus
Appian Medical’s SnoreSounds
Computmedics Sleep Pty’s Compumedics Sleep Monitoring System
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