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

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 monitoring is risky – and so too is a one-size-fits-all approach to index-based monitoring.”

“In Europe, where pediatric SedLine monitoring with the PSi has been available for several years, we have found the index particularly useful in helping us optimize depth of sedation in children and believe it adds significant value to our pediatric anesthesia practices. From a practical perspective, the PSi is also helpful because without it, it’s difficult to trend and record brain function data in patient charts, since you cannot trend DSA or raw EEG data,” concluded Dr. Ricci.

“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,” said Dr. Basil Matta, Chief Medical Officer at Masimo, added. “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,” concluded Dr. Matta.

Indices like PSi can be particularly helpful in offering quick insight, moment-by-moment, into a patient’s brain function under anesthesia – especially when derived from high-quality, comprehensive data and appropriately calibrated for the patient’s age group. Masimo PSi also offers the unique ability to be trended and included in the hospital’s electronic medical record (EMR). Pediatric SedLine, first cleared by the FDA in 2022, is the only depth of sedation monitoring solution indicated for children as young as one year old. Now, accelerating the impact and reach of brain monitoring technology, clinicians gain the added benefit of index-based insights during the sedation of pediatric patients four years and older, confident in the knowledge that the algorithm driving PSi values was calibrated for that specific use case.

Various studies have raised concerns about using sedation scores designed for adults to monitor children’s brains^4,5 – highlighting the need for more refined scoring solutions and the benefits of an index like PSi customized to reflect pediatric physiology. To achieve this first-ever clearance, Masimo researchers submitted clinical data showing how Masimo’s innovative pediatric PSi algorithm – the result of years of careful development and refinement – was equipped to accommodate the unique physiology of children’s brains under anesthesia. Using data from 169 pediatric patients, pediatric PSi scoring was shown to be responsive and well correlated with manually scored stages of anesthesia and instances of burst suppression (a sign of potential oversedation, more common in pediatric brains even when exposed to standard-of-care levels of anesthetic drugs).⁶ Comparison of that data with published data evaluating competitor technology – technology not calibrated for pediatric brains – confirmed pediatric PSi’s superior performance.⁷

In the U.S., SedLine brain function monitoring is indicated for use on adults and on children one year and older; the PSi feature is indicated for use on children four years and older.