Irvine, California-based Masimo — which became a part of Danaher through a $10 billion acquisition last month — said the PSi represents the first-and-only sedation score specifically designed for the unique physiology of the pediatric brain. It works as a key function of the Masimo SedLine brain function monitoring platform.
SedLine processes and displays EEG signals from both halves of the brain. It also offers a multi-taper Density Spectral Array (DSA) and PSi. The platform offers clinicians a more complete picture of the brain under anesthesia, Masimo says.
PSi helps helps clinicians monitor depth of sedation in children four years and older in the operating room and ICU. The newly cleared offering addresses the different responses children’s brains have to anesthesia. It features an algorithm specifically calibrated and validated for pediatric patients.
Masimo said Pediatric PSi also represents the first-and-only index derived from bilateral brain data. The company said it’s the only index indicated for pediatric use with both propofol and sevoflurane, two of the most common anesthetic drugs.
SedLine’s U.S. indication covers adults and children one year and older. The PSi feature’s indication covers use on children four years and older.
Dr. Basil Matta, Masimo chief medical officer, said:
“As we learn more about how children’s brains function and respond to anesthesia, the value of sedation monitoring specifically designed for pediatric patients becomes more clear. This FDA clearance is the result of close collaboration with numerous anesthesiologists to solve one of the hardest problems, together: how to equip care teams with the most reliable insights into what is happening in young brains in their most vulnerable moments, when sedated during surgery or in the ICU.
“Older technologies rely on unilateral data, or crudely apply algorithms designed for adult brains to children without taking their unique physiology into account. We believe that pediatric PSi, by comparison, offers significant advantages to anesthesiologists, expanding their ability to optimize sedation for children to reduce the risk of oversedation and rate of postsurgical complications. It’s a great example of how Masimo is accelerating breakthroughs from discovery to delivery, moving at speed but with clinical and technical rigor to transform ideas into real-world impact.”
