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

News provided by Masimo Corporation 

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

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.

 

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