Masimo Wins FDA Nod for Pediatric Patient State Index

Masimo, a Danaher company, announced that it’s earned U.S. Food and Drug Administration (FDA) 510(k) clearance for the Patient State Index (PSi) for pediatric patients.

According to the company, PSi is the first sedation score specifically engineered for the pediatric brain’s unique physiology. A feature of SedLine brain function monitoring, pediatric PSi helps monitor depth of sedation in children four and up in the OR and ICU.

The FDA-cleared pediatric PSi is the first index derived from bilateral brain data indicated for pediatric use with both propofol and sevoflurane, according Masimo. It boasts an algorithm calibrated and validated for pediatric patients.

Masimo SedLine processes and displays EEG signals from both hemispheres, a Density Spectral Array (DSA), and the PSi, a proprietary EEG-derived parameter, to monitor brain activity during anesthesia. It can also be trended and included in the hospital’s electronic medical record.

Comments from Masimo exec and clinician

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: “The risks of oversedating pediatric brains are significant. 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 monitoring is risky—and so too is a one-size-fits-all approach to index-based monitoring.”

Dr. Basil Matta, chief medical officer, Masimo: “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.”