Expanded Clearance for Masimo SedLine^® Enables Clinicians to Track Brain Activity and Sedation Depth in Young Patients with Added Assurance

Masimo, a Danaher company and innovator focused on pulse oximetry plus additional patient monitoring tools, announced today FDA 510(k) clearance for the Patient State Index (PSi) in pediatric use. This marks the first sedation score created specifically for the distinct physiology of developing brains and reflects how Masimo and Danaher speed ideas into meaningful results. As a central element of Masimo SedLine^® brain function monitoring, the pediatric PSi supports clinicians in assessing sedation depth for children aged four and above in both operating rooms and intensive care units.

Young brains react to anesthesia in ways that differ from adult responses, which can complicate efforts to monitor sedation accurately. The newly cleared pediatric PSi meets this challenge through an algorithm tuned and tested for pediatric patients, now available to assist anesthesiologists. It remains the sole index based on bilateral brain data, like the adult version, and stands as the only index cleared for pediatric application with both propofol and sevoflurane, two widely used anesthetic agents.

Masimo SedLine assists clinicians by processing and showing electroencephalogram signals from each side of the brain, together with a multi-taper Density Spectral Array and the PSi value, a proprietary computed EEG metric. This combination supplies a fuller view of brain activity under anesthesia than rival systems. Proper sedation depth monitoring plays a vital role in avoiding anesthesia-related issues and supporting quicker recovery.

"The dangers of oversedating pediatric brains are considerable," noted 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 delicacy makes it more difficult to reach and sustain suitable sedation levels while raising the likelihood that excess sedation will cause postoperative problems. Relying on standard dosing guidelines without depth of sedation monitoring carries risk, as does applying a uniform approach to index-based monitoring."

"In Europe, where pediatric SedLine monitoring with the PSi has been in use for several years, we have seen the index prove valuable in optimizing sedation depth for children and believe it brings meaningful benefit to our pediatric anesthesia work. Practically, the PSi also aids because without it, trending and recording brain function data in patient charts proves difficult, since DSA or raw EEG data cannot be trended," added Dr. Ricci.

"As understanding grows about how children's brains operate and respond to anesthesia, the benefit of sedation monitoring designed expressly for pediatric patients becomes clearer," said Dr. Basil Matta, Chief Medical Officer at Masimo. "This FDA clearance stems from close work with many anesthesiologists to address one of the toughest challenges together: supplying care teams with the most dependable insights into young brains during their most vulnerable periods under sedation in surgery or the ICU."

"Earlier technologies depend on single-side data or apply adult-focused algorithms to children without accounting for their distinct physiology. We believe pediatric PSi delivers clear advantages to anesthesiologists by broadening their capacity to fine-tune sedation for children, lowering oversedation risk and postsurgical complication rates. It exemplifies how Masimo accelerates breakthroughs from discovery to delivery, advancing swiftly yet with clinical and technical precision to turn concepts into tangible results," concluded Dr. Matta.

Indices such as PSi can supply rapid, moment-to-moment insight into brain function under anesthesia, particularly when drawn from high-quality, comprehensive data and properly adjusted for the patient's age group. Masimo PSi further provides the distinctive option to trend and store values in the hospital electronic medical record. Pediatric SedLine, first cleared by the FDA in 2022, remains the only depth of sedation monitoring solution indicated for children as young as one year. With this clearance, clinicians now gain index-based insights during sedation of pediatric patients four years and older, assured that the algorithm behind PSi values was calibrated for that exact purpose.

Multiple studies have highlighted concerns over applying adult-designed sedation scores to monitor children's brains, underscoring the need for refined scoring options and the advantages of an index like PSi adjusted to reflect pediatric physiology. To secure this first clearance, Masimo researchers presented clinical data demonstrating how the pediatric PSi algorithm, developed and refined over years, accommodates the unique physiology of children's brains under anesthesia. Data from 169 pediatric patients showed pediatric PSi scoring responded well and correlated with manually scored anesthesia stages and burst suppression events, a potential oversedation indicator more frequent in pediatric brains even at standard anesthetic levels. Comparison with published data on competitor technology, not calibrated for pediatric brains, confirmed superior performance of pediatric PSi.

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

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References

Davidson et al. Current Anesthesiology Reports 3. 1 (2013): 57-63.
Cornelissen L et al. Elife 4 (2015): e06513.
Musialowicz et al. Current Anesthesiology Reports 4. 3 (2014): 251-260.
Liu JS et al. Variation of bispectral index monitoring in paediatric patients undergoing propofol-remifentanil anaesthesia. Eur J Anaesthesiol. 2008 Oct;25(10):821-5.
Sciusco A et al. Effect of age on the performance of bispectral and entropy indices during sevoflurane pediatric anesthesia: a pharmacometric study. Pediatric Anesthesia. 2017 Apr;27(4):399-408.
Masimo data on file.
Shields C et al. Clinical Utility of the Bispectral Index Score When Compared to the University of Michigan Sedation Scale in Assessing the Depth of Outpatient Pediatric Sedation. Clinical Pediatrics. 2005. doi: 10.1177/000992280504400306.

About Masimo
Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is for our innovations to empower clinicians to transform patient care. Masimo SET^® Measure-through Motion and Low Perfusion pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at www.masimo.com/evidence/featured-studies/feature. Masimo SET^® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2026 Newsweek World's Best Hospitals listing. Additional information about Masimo and its products may be found at www.masimo.com.

About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve many of their most complex scientific and clinical challenges, helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our more than 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

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SOURCE Masimo Corporation