Masimo 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.
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.
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. Its 510(k) is pending in the U.S.
