FDA Clears Masimo Pediatric Regional Oximetry

FDA has cleared a Masimo 510(k) for a pediatric indication for its O3 regional oximetry with an 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,” the company says. The clearance of the O3 pediatric sensor covers regional oximetry monitoring for pediatric patients weighing more than 5 kg (11 lbs) and less than 40 kg (88 lbs).

Masimo says the O3 regional oximetry uses near-infrared spectroscopy to continuously monitor “absolute and trended regional tissue oxygen saturation in the cerebral region. Early detection and correction of imbalances in oxygen delivery to the brain are important tools in helping patients avoid postoperative morbidity and adverse outcomes.”