The 9 AI algorithms FDA-cleared for anesthesiology

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, 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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