{"id":41333,"date":"2026-08-19T02:11:29","date_gmt":"2026-08-19T02:11:29","guid":{"rendered":"https:\/\/g-medtech.com\/news\/?p=41333"},"modified":"2026-08-20T02:17:35","modified_gmt":"2026-08-20T02:17:35","slug":"masimo-receives-ce-mark-for-ai-powered-smartsedline-brain-function-monitor","status":"publish","type":"post","link":"https:\/\/g-medtech.com\/news\/masimo-receives-ce-mark-for-ai-powered-smartsedline-brain-function-monitor\/","title":{"rendered":"Masimo Receives CE Mark for AI-Powered smartSedLine Brain Function Monitor"},"content":{"rendered":"\n

Masimo<\/a>, a Danaher<\/a> company specializing in patient-monitoring solutions, has announced CE Mark approval for smartSedLine, its next-generation brain function monitor. The device features an AI-powered Patient State Index algorithm designed to deliver an index that is more responsive to underlying brain activity and provides increased stability during anesthesia. The milestone represents another example of how Masimo and Danaher are applying advanced science and technology to move innovation from discovery to delivery for clinicians and patients.<\/p>\n\n\n\n

smartSedLine continuously processes and displays four real-time bilateral frontal EEG waveforms and generates 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. 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, which can be an issue with geriatric and critically ill patients. These enhancements are intended to deliver a PSi that better reflects underlying brain activity, helping clinicians optimize anesthetic management from the start.<\/p>\n\n\n\n

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

smartSedLine builds on Masimo’s 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. smartSedLine PSi has received the CE Mark and will be available in applicable markets, and is 510(k) pending in the United States.<\/p>\n","protected":false},"excerpt":{"rendered":"

Masimo has received CE Mark for smartSedLine, its next-generation brain function monitor featuring an AI-powered Patient State Index algorithm designed to deliver faster responsiveness during anesthesia induction and greater stability in challenging low-power EEG conditions.<\/p>\n","protected":false},"author":2,"featured_media":41334,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"colormag_page_layout":"default_layout","footnotes":""},"categories":[488,681,6,25],"tags":[704],"class_list":["post-41333","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-breaking-news","category-care-therapy","category-europe","category-products-technologies","tag-ce-mark"],"_links":{"self":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/41333","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/comments?post=41333"}],"version-history":[{"count":4,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/41333\/revisions"}],"predecessor-version":[{"id":41350,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/posts\/41333\/revisions\/41350"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media\/41334"}],"wp:attachment":[{"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/media?parent=41333"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/categories?post=41333"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/g-medtech.com\/news\/wp-json\/wp\/v2\/tags?post=41333"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}