Noninvasive monitoring technologies provider Masimo has secured CE mark approval for next generation SedLine brain function monitoring for pediatric patients aged between 1to18.
Image: Masimo Root with next generation SedLine brain function monitoring system. Photo: courtesy of Masimo.
The SedLine system will help clinicians monitor the state of the brain under anesthesia with bilateral data acquisition and processing of four leads of electroencephalogram (EEG) signals.
It will take the support of pediatric-specific signal processing engine to optimize performance of Masimo’s processed EEG parameter, Patient State Index (PSi), when monitoring pediatric patients one year old and above.
Management of an appropriate level of anesthesia will help prevent anesthesia-related events, enabling to recover rapidly.
Supported by pediatric-specific engine, the PSi in SedLine will enable clinicians interpret the EEGs of challenging population.
The next generation SedLine provides significant improvements compared to original SedLine, including PSi with less susceptibility to electromyography (EMG) interference and multitaper density spectral array (DSA) that can optimize visibility of EEG features.
Masimo secured approval from the US Food and Drug Administration (FDA) for adults. It is not currently indicated for pediatric patients in the US.
Masimo founder and CEO Joe Kiani said: “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.”
In July 2018, Masimo launched Vital Signs Check Application, which is an integrated patient data collection and workflow application for the Masimo Root patient monitoring and connectivity platform.
Vital Signs Check, available for new and existing Root customers through a software upgrade, augments Root’s versatility by helping to automate hospital vital signs testing workflows.
Masimo, which offers advanced noninvasive monitoring technologies, first introduced Masimo SET measure-through motion and Low Perfusion pulse oximetry in 1995.