FDA Clears Pediatric Sedation Index for Masimo SedLine Brain Monitoring

The FDA granted 510(k) clearance for the pediatric Patient State Index (PSi; Masimo, Irvine, CA), an index-based sedation score for use with the Masimo SedLine brain function monitoring platform in children aged 4 years and older.

SedLine processes and displays bilateral electroencephalogram data, along with a Density Spectral Array and PSi, to support brain function and depth-of-sedation monitoring. In the United States, SedLine brain function monitoring is indicated for adults and children aged 1 year and older; the newly cleared PSi feature is indicated for children aged 4 years and older.

Clearance Highlights

• Pediatric PSi is calibrated for pediatric brain physiology and is intended for use in the operating room and intensive care unit.
• The index is derived from bilateral brain data and is indicated for pediatric use with propofol and sevoflurane.
• Masimo submitted clinical data from 169 pediatric patients showing that pediatric PSi was responsive and correlated with manually scored anesthesia stages and burst suppression.
• Burst suppression, which can indicate potential oversedation, was included as part of the algorithm validation data.

The company stated that pediatric PSi may help clinicians trend sedation-related brain function data and incorporate the index into electronic medical records. The clearance expands the SedLine platform’s pediatric monitoring capabilities but does not replace clinical judgment or full EEG interpretation.

Source

Masimo Corporation. 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. News release. July 27, 2026.