Masimo Wins FDA Clearance of O3 Regional Oximetry for Pediatric Patients

The FDA has granted marketing clearance for Masimo’s pediatric indication for O3 regional oximetry with the O3 pediatric sensor.

O3 regional oximetry monitoring, which was already available for adult patients in the United States, is now also available for pediatric patients weighing more than 11 pounds and less than 88 pounds.

O3 regional oximetry uses near-infrared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. — Cynthia Jessup