Masimo (NSDQ:MASI) said today that it won FDA clearance for use of its O3 Regional Oximetry system with neonatal and infant patients.
The Irvine, Calif.-based company’s technology uses near-infrared spectroscopy to assess the regional hemoglobin oxygen saturation of blood on both sides of the brain.
The O3 sensors are now available in sizes to fit adult, pediatric and infant patients, according to Masimo and are designed to fit easily and comfortably on all patients’ foreheads.
The company’s O3 system is available as a module for its Root patient monitoring and connectivity platform. The Root platform enables doctors to simultaneously monitor patients using O3 and other technology, including Masimo’s SET pulse oximetry.
“From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET pulse oximetry was designed with neonates and infants in mind. These patients were not an afterthought. This focus has paid off for these young patients: SET pulse oximetry has helped clinicians reduce the incidence of severe retinopathy of prematurity (ROP) in neonates and improve critical congenital heart disease (CCHD) screening in newborns,” founder & CEO Joe Kiani said in prepared remarks.
“O3 Regional Oximetry, with its ability to help clinicians accurately track cerebral oxygen saturation, will hopefully have a similar impact. We are happy to be able to bring O3’s advanced capabilities and accuracy to the neonatal patient population,” Kiani added.