Irvine, Calif., July 27, 2026
Masimo, a Danaher company and global leader in patient monitoring technologies, has received U.S. FDA 510(k) clearance for the Pediatric Patient State Index (PSi), becoming the first-and-only sedation score specifically designed for the unique physiology of the pediatric brain. The newly cleared technology expands the capabilities of Masimo SedLine® brain function monitoring, enabling clinicians to more accurately monitor the depth of sedation in children aged four years and older during procedures performed in the operating room (OR) and intensive care unit (ICU). The regulatory milestone represents a major advancement in pediatric anesthesia monitoring, providing anesthesiologists with a clinically validated tool developed specifically for children rather than relying on adult-based algorithms. By delivering more precise neurological insights during anesthesia, the innovation supports safer sedation management, improved patient outcomes, and greater confidence in pediatric critical care.
FDA 510(k) Clearance Brings Pediatric-Specific Brain Monitoring
The FDA 510(k) clearance introduces a significant advancement in pediatric monitoring by making Pediatric PSi the first FDA-cleared sedation index specifically calibrated for children’s unique neurological responses to anesthesia. Unlike conventional monitoring systems that adapt algorithms originally designed for adults, the new Pediatric Patient State Index was developed and validated using pediatric-specific clinical data. The proprietary algorithm analyzes bilateral electroencephalogram (EEG) signals captured through Masimo SedLine®, providing clinicians with comprehensive information about brain function and sedation depth during surgery and critical care. The technology is also the only pediatric sedation index indicated for use with both propofol and sevoflurane, two of the most commonly administered anesthetic agents in pediatric medicine. This specialized approach helps anesthesiologists better assess sedation levels while reducing uncertainty associated with monitoring developing brains under anesthesia.
Clinical Validation Demonstrates Improved Sedation Monitoring
Masimo’s FDA clearance was supported by extensive clinical evidence involving 169 pediatric patients, demonstrating that the Pediatric PSi algorithm accurately reflects different stages of anesthesia and effectively identifies burst suppression, an important indicator of potential oversedation that occurs more frequently in children. Researchers showed that the pediatric-specific algorithm produced strong correlations with manually scored anesthesia stages while outperforming existing monitoring technologies that rely on adult-derived scoring systems. The technology enables clinicians to continuously monitor brain activity, EEG signals, Density Spectral Array (DSA), and the proprietary Patient State Index, providing a more complete understanding of neurological function throughout surgical procedures and intensive care treatment. In addition to supporting safer anesthesia management, the Pediatric PSi can be integrated into electronic medical records (EMRs), allowing clinicians to trend sedation data over time and improve documentation for pediatric patients.
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Innovation Strengthens Pediatric Anesthesia and Critical Care
The FDA clearance further strengthens Masimo’s leadership in advanced patient monitoring technologies and reflects continued innovation in pediatric anesthesia, critical care, and brain function monitoring. While Masimo SedLine® has been FDA-cleared for children aged one year and older since 2022, the addition of the Pediatric Patient State Index now provides clinicians with a dedicated, age-specific sedation score for children four years and older. The technology addresses growing clinical concerns regarding the limitations of adult-based monitoring systems when used in pediatric populations and supports more individualized anesthesia management. As hospitals increasingly adopt precision monitoring technologies to improve patient safety, Pediatric PSi provides anesthesiologists with a scientifically validated solution designed specifically for young patients. This milestone reinforces Masimo’s commitment to advancing medical technology, improving pediatric surgical care, and delivering innovative monitoring solutions that enhance clinical decision-making and reduce the risk of anesthesia-related complications.
Source: Masimo press release
