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
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.