Masimo Receives CE Mark for AI-Powered smartSedLine™ Brain Function Monitor to Advance Anesthetic Management

Next-Generation PSi Algorithm Is Designed to Respond Faster During Induction and Provide Greater Stability in Challenging Low-Power EEG Conditions

IRVINE, Calif., Aug. 18, 2026 /PRNewswire/ -- Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient-monitoring solutions, today announced CE Mark for smartSedLine™, its next-generation brain function monitor featuring an AI-powered Patient State Index (PSi) algorithm designed to deliver an index that is more responsive to underlying brain activity and provides increased stability during anesthesia. This milestone is another example of how Masimo and Danaher are accelerating ideas to impact, applying advanced science and technology to move meaningful innovation from discovery to delivery for clinicians and the patients who depend on them.

smartSedLine continuously processes and displays four real-time bilateral frontal electroencephalogram (EEG) waveforms and generates a range of key parameters to help clinicians assess a patient's anesthesia state and overall brain function. One of its primary outputs is PSi, an index ranging from 0 to 100 that reflects the patient's level of sedation. With enhanced responsiveness and reliability, smartSedLine is designed to support optimized anesthetic management and more individualized patient care.

Compared with the previous-generation SedLine algorithm, smartSedLine is designed to provide a more responsive PSi during induction and increased stability under low EEG power. Low EEG power can be an issue with geriatric and critically ill patients. Together, these enhancements are designed to deliver a PSi that better reflects underlying brain activity, helping clinicians optimize anesthetic management from the start.

"The brain can change rapidly under anesthesia, and clinicians need information that responds to those changes while remaining reliable in challenging conditions," said Dr. Basil Matta, Consultant in Critical Care, Affiliated Professor at the University of Cambridge and Chief Medical Officer at Masimo. "With smartSedLine, we are applying advanced AI techniques to brain function monitoring to deliver a more responsive Patient State Index that better reflects underlying brain activity. By improving responsiveness during induction and stability under low EEG power, we can provide clinicians with meaningful insights to help individualize anesthetic management for each patient."

smartSedLine builds on Masimo's longstanding innovation in brain function monitoring and represents another step in the evolution of the company's broader Brain Health Platform, including O3® Regional Oximetry. By combining advanced algorithms, AI techniques, and continuous bilateral EEG data, Masimo is working to transform complex brain activity into more responsive and reliable insights for clinicians—helping them better understand how individual patients respond to anesthesia and make more informed decisions throughout care.

The smartSedLine Sedation Monitor is intended to monitor the state of the brain through real-time data acquisition and processing of EEG signals.

smartSedLine PSi has received CE Mark and will be available in applicable markets. smartSedLine PSi is 510(k) pending in the U.S.

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 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 approximately 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.

Forward-Looking Statements and Other Information

Statements in this release that are not strictly historical, including the statements regarding the potential impact and benefits of smartSedLine, and any other statements regarding events or developments that we believe or anticipate will or may occur in the future are "forward-looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause Danaher Corporation's and its subsidiaries' actual results, developments and business decisions to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. 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Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in Danaher Corporation's SEC filings, including Danaher Corporation's 2025 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the first quarter of 2026. These forward-looking statements speak only as of the date of this release and except to the extent required by applicable law, Danaher Corporation does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise.

Media Contact:

Christine McCullough
Masimo Head of Corporate Communications
[email protected]

SOURCE Masimo Corporation