March 1, 2022 – Masimo announced the FDA clearance of SedLine® brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. With this clearance, the potential benefits of SedLine have been expanded to all patients one year old and above in the United States. Equipped with Masimo’s advanced signal processing technology, SedLine helps clinicians monitor brain activity bilaterally by processing electroencephalogram (EEG) signals from Masimo’s four-lead SedLine EEG sensors.
This clearance brings Masimo’s bilateral brain activity monitoring to children 1 to 17 years old, in conjunction with specially sized pediatric sensors designed for easier application on smaller pediatric foreheads. Brain activity monitoring under anesthesia on pediatric patients is different from that of adults. Maintaining an appropriate depth of anesthesia is key to preventing anesthesia-related events and enabling faster recovery. To aid clinicians in monitoring anesthesia depth on children, SedLine features both the display of EEG signals and the Multitaper Density Spectral Array (DSA) from both sides of the brain, to provide clinicians with a more complete picture of the brain.