Masimo Announces FDA 510(k) Clearance of O3 Regional Oximetry for Pediatric Patients

Masimo has announced FDA 510(k) clearance for the pediatric indication for O3 regional oximetry with the O3 pediatric sensor. Regional oximetry, also referred to as tissue or cerebral oximetry, may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain. With the clearance of 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 (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region.

In addition, Masimo O3 regional oximetry and SedLine brain function monitoring are both available on a single platform, Masimo Root – opening up a path to better understanding of the brain.