FDA clears pediatric Patient State Index for Masimo SedLine sedation monitoring

Children undergoing anesthesia in the operating room or intensive care unit now have access to a sedation-monitoring index built specifically around pediatric brain physiology, following FDA 510(k) clearance of the pediatric Patient State Index (PSi) for Masimo SedLine brain function monitoring.¹ The clearance covers children aged 4 years and older and applies to use with propofol and sevoflurane, 2 of the most commonly used anesthetic agents in pediatric care.¹

"The risks of oversedating pediatric brains are significant," said Zaccaria Ricci, MD, director of anesthesiology and the pediatric intensive care unit at Meyer Children's Hospital and associate professor in the Department of Health Science at the University of Florence, Italy. Ricci noted that children's physiological fragility makes it harder to achieve and sustain appropriate sedation levels and raises the likelihood that oversedation will contribute to postoperative complications, adding that a one-size-fits-all approach to index-based monitoring carries its own risks.¹

Pediatric PSi validation data and FDA clearance details

To support the clearance, Masimo submitted data from 169 pediatric patients showing that pediatric PSi scoring correlated with manually scored stages of anesthesia and with episodes of burst suppression, an EEG pattern associated with oversedation that occurs more frequently in children than adults even at standard-of-care anesthetic dosing.¹ When compared against previously published performance data for a competing EEG-based index not calibrated for pediatric physiology, Masimo reported that pediatric PSi performed better.¹ The company has characterized this as the first algorithm of its kind validated and cleared specifically for pediatric use, rather than adapted from an adult model.

Sedation monitoring challenges in the developing pediatric brain

The pediatric brain's electrical activity under anesthesia differs meaningfully from that of adults, a distinction increasingly documented in the anesthesiology literature. Sevoflurane-induced EEG patterns in infants change substantially with age during the first years of life, reflecting rapid developmental shifts in brain connectivity and oscillatory activity.² Research evaluating EEG-derived indices originally designed for adults has similarly found that their performance in children varies by age, raising questions about applying adult-derived thresholds to younger patients undergoing sevoflurane anesthesia.³ These findings underpin the clinical rationale for an index built and validated on pediatric data from the outset.

SedLine and PSi mechanism of action

SedLine monitoring works by processing EEG signals from both hemispheres of the brain, generating PSi—a proprietary, computed EEG variable—alongside a density spectral array display. Masimo first received FDA clearance for pediatric SedLine brain function monitoring, covering children 1 to 17 years old, along with a dedicated pediatric EEG sensor, in 2022.⁴ The newly cleared pediatric PSi builds on that hardware clearance by adding an index calibrated for children 4 years and older, giving clinicians a trendable, chartable score rather than relying solely on raw EEG or spectral array interpretation.

Clinical perspective on pediatric depth-of-sedation monitoring

Basil Matta, MD, chief medical officer at Masimo, framed the clearance as a response to a persistent gap in pediatric anesthesia practice: "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." Ricci, who has used SedLine's pediatric PSi in Europe, said the index has helped optimize sedation depth in his practice and noted its practical value for documentation, since raw EEG and spectral array data are otherwise difficult to trend in a patient's chart.¹

References

1. Masimo Corporation. Masimo receives FDA 510(k) clearance for the Pediatric Patient State Index. PR Newswire. July 27, 2026. Accessed July 28, 2026. https://www.prnewswire.com/news-releases/masimo-receives-fda-510k-clearance-for-the-pediatric-patient-state-index-the-first-and-only-sedation-score-specifically-designed-for-the-unique-physiology-of-the-pediatric-brain-302834521.html

2. Cornelissen L, Kim SE, Purdon PL, Brown EN, Berde CB. Age-dependent electroencephalogram (EEG) patterns during sevoflurane general anesthesia in infants. Elife. 2015;4:e06513. Published 2015 Jun 23. doi:10.7554/eLife.06513

3. Sciusco A, Standing JF, Sheng Y, Raimondo P, Cinnella G, Dambrosio M. Effect of age on the performance of bispectral and entropy indices during sevoflurane pediatric anesthesia: a pharmacometric study. Paediatr Anaesth. 2017;27(4):399-408. doi:10.1111/pan.13086

4. Masimo Corporation. Masimo announces FDA clearance of pediatric indication for SedLine brain function monitoring and the SedLine Pediatric EEG Sensor. BusinessWire. February 28, 2022. Accessed July 28, 2026. https://www.businesswire.com/news/home/20220228005286/en/Masimo-Announces-FDA-Clearance-of-Pediatric-Indication-for-SedLine-Brain-Function-Monitoring-and-the-SedLine-Pediatric-EEG-Sensor