Masimo Receives FDA 510(k) Clearance for the Pediatric Patient State Index, the First-and-Only Sedation Score Specifically Designed for the Unique Physiology of the Pediatric Brain

About this update from Masimo Corporation

Additional Clearance for Masimo SedLine® Empowers Clinicians to Monitor Brain Function and Depth of Sedation in Children with Greater Confidence IRVINE, Calif., July 27, 2026 /PRNewswire/ -- Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient-monitoring solutions, today announced FDA 510(k) clearance for the Patient State Index (PSi) for pediatric patients, the first-and-only sedation score specifically designed for the unique physiology of the pediatric brain, and an example of how Masimo and Danaher are accelerating ideas to impact. A key feature of Masimo SedLine® brain function monitoring, pediatric PSi helps clinicians monitor depth of sedation in children four years and older in the operating room (OR) and intensive care unit (ICU). Children's brains respond differently to anesthesia than adults', making accurate sedation monitoring more challenging.1,2 The newly cleared pediatric PSi addresses that need with an algorithm specifically calibrated and validated for pediatric patients, available to support anesthesiologists for the first time. Pediatric PSi is also the first-and-only index derived from bilateral brain data (as is the PSi for adult patients), and the only index indicated for pediatric use with both propofol and sevoflurane, two of the most common anesthetic drugs. Masimo SedLine helps clinicians monitor brain activity by processing and displaying electroencephalogram (EEG) signals from both halves of the brain, alongside a multi-taper Density Spectral Array (DSA) and PSi, a proprietary, computed EEG variable – providing clinicians with a more complete picture of the brain under anesthesia than competitor technologies. Appropriate depth of sedation monitoring is key to preventing anesthesia-related events and enabling faster recovery.3  "The risks of oversedating pediatric brains are significant," said Professor Zaccaria Ricci, MD, Director of Anesthesiology and the PICU at Meyer Children's Hospital and Associate Professor in the Department of Health Science at the University of Florence, Italy. "Their fragility makes it harder to achieve and maintain appropriate levels of sedation and also increases the chances that oversedation will lead to postoperative complications. Sedating children using standard-of-care dosing guidelines without depth of sedation monito...

View stock analysis, news, and events for Masimo Corporation