Masimo (NSDQ:MASI) said today that it won CE Mark approval in the European Union for its next-gen SedLine brain function monitor intended for pediatric patients.
The Irvine, Calif.-based company said that with the clearance, its next-gen SedLine monitoring tech is now available for all patients one year and older in CE Mark countries.
Masimo said that the SedLine system is designed to allow clinicians to monitor the state of the brain while patients are under anesthesia. The company added that the system features a pediatric-specific signal processing engine intended to improve the performance of the company’s processed electroencephalogram parameter when monitoring pediatric patients.
The newly cleared system also features improvements over the first-gen SedLine including a reduced susceptibility to electromyography interference and a multitaper density spectral array.
“Next Generation SedLine is doing for brain function monitoring what Masimo SET did for pulse oximetry. We believe Next Generation SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging brains are appropriately anesthetized. We are gratified that its benefits are now available to those younger patients whose brains are particularly delicate and to whose wellbeing Masimo has always been so committed,” founder & CEO Joe Kiani said in a press release.
In late January, Masimo said it won FDA clearance for its respiration rate measurement from the pleth RRp on its MightySat Rx spot-check fingertip pulse oximeter.
