Tuesday, May 30, 2017
Masimo Gets FDA Clearance On Pediatric Product
Irvine-based medical device maker Masimo announced this morning that it has received FDA 510(k) clearance on its O3 Regional Oximetry sensor for pediatric patients. Masimo's product is used to measure the amount of oxygen in the brain, and uses near-infrared spectroscopy (NIRS) to continuously monitor absolute and trended regional tissue oxygen saturation (rSO2) in the cerebral region. The company said the product is now available for pediatric patients weighing more than 5 kg (11 lbs) and less than 40 kg (88 lbs).