FDA OKs Neonatal Indication for Masimo’s O3 Regional Oximetry

Masimo announced that O3 Regional Oximetry has received FDA clearance for use on neonatal and infant patients (<10 kg). O3 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 this expansion of the O3 platform, the benefits of monitoring with O3 are now available to patients of all ages, from neonates to adults.
 
O3, which uses near-infrared spectroscopy (NIRS) to monitor the regional hemoglobin oxygen saturation of blood (rSO2) on both sides of the brain, may be particularly helpful in providing insight into neonatal patient status because neonatal pathology is often brain-related.1 In neonates, O3 provides reliable measurement with a 3 percent ARMS* trending accuracy specification.
 
O3 sensors are available in three sizes, for adult (≥40 kg), pediatric (≥5 kg and <40 kg) and now infant and neonatal (<10 kg) patients. With its smaller size and flexible design, the neonatal sensor is designed to fit easily and comfortably on the delicate foreheads of tiny patients.
 
O3 is available as a Masimo Open Connect (MOC-9) module for the Root Patient Monitoring and Connectivity Platform. Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3 and other measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry, providing clinicians with expanded visibility of neonatal oxygenation status. Additional modalities available on Root include advanced rainbow noninvasive measurements such as total hemoglobin (SpHb), SedLine brain function monitoring (available for adult patients), NomoLine capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with Masimo Patient SafetyNet or Iris Gateway, monitoring data from O3 can be automatically charted in electronic medical records (EMRs).
 
Joe Kiani, Founder and CEO of Masimo, said, “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 neonates2 and improve critical congenital heart disease (CCHD) screening in newborns.3 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.”