Masimo Gains CE Mark for AI-Powered Brain Monitor

Irvine, California, August 18, 2026

AI-Powered Algorithm Targets Faster Anesthesia Response

The smartSedLine system continuously acquires and displays four real-time bilateral frontal EEG waveforms, while generating multiple parameters intended to help clinicians assess a patient’s anesthesia state and overall brain function. Its primary PSi output ranges from 0 to 100 and reflects the patient’s level of sedation. According to Masimo, the new AI-powered algorithm has been developed to address limitations that can occur during challenging anesthesia conditions. Compared with the previous-generation SedLine algorithm, smartSedLine is designed to provide greater responsiveness during induction and improved stability when EEG power is low. These capabilities may be particularly relevant when monitoring patients whose EEG signals are more difficult to interpret. Geriatric and critically ill patients can experience low EEG power, creating challenges for brain-function monitoring. By improving algorithmic stability in these conditions, the company aims to provide clinicians with information that more consistently reflects underlying brain activity. The system is intended to support clinicians from the beginning of anesthesia through ongoing care by translating complex EEG signals into a more accessible measure of sedation state.

Continuous EEG Monitoring Supports Individualized Care

The smartSedLine monitor builds on Masimo’s existing work in brain function monitoring and forms part of the company’s broader Brain Health Platform, which also includes O3® Regional Oximetry. The platform approach combines continuous physiological measurements with advanced software and algorithms to provide clinicians with additional information about brain function. The new PSi algorithm uses AI techniques and continuous bilateral EEG data to analyze brain activity in real time. The objective is to provide a more responsive index that can help clinicians understand how individual patients are responding to anesthesia and make appropriate adjustments during care. Anesthesia can produce rapid changes in brain activity, making timely physiological information important for clinical management. Masimo says the enhanced responsiveness and stability of smartSedLine are designed to help clinicians optimize anesthetic management while supporting a more individualized approach to patient care. The technology is intended to monitor the state of the brain through real-time acquisition and processing of EEG signals. Rather than functioning as a standalone therapeutic technology, the system provides monitoring information intended to support clinical assessment during anesthesia.

CE Mark Opens Access in Applicable Markets

The CE Mark clearance allows smartSedLine PSi to become available in applicable markets, representing an important regulatory milestone for Masimo’s next-generation brain monitoring technology. The company stated that the product will be available in markets where the CE Mark applies. In the United States, however, smartSedLine PSi remains 510(k) pending, meaning the technology is not yet cleared for U.S. marketing under the described indication. The development reflects the broader movement toward AI-enabled medical devices that combine physiological data with advanced computational algorithms. For anesthesia care, where brain activity can change rapidly and monitoring conditions can vary between patients, improvements in signal processing and algorithm stability may provide clinicians with additional tools for real-time assessment. With the CE Mark now secured, Masimo is positioned to advance the availability of smartSedLine in applicable markets and continue developing its Brain Health Platform. The technology represents a further step toward integrating EEG, AI and continuous brain-function monitoring into modern anesthetic management.

Source: Masimo press relese