Masimo has received a CE marking for its Next Generation SedLine brain function monitoring for pediatric patients (1-18 years of age).

SedLine helps clinicians monitor the state of the pediatric brain under anesthesia with bilateral data acquisition and processing of four leads of electroencephalogram (EEG) signals.

SedLine uses a pediatric-specific signal processing engine to improve performance of Masimo’s processed EEG parameter, the Patient State Index (PSi), when monitoring pediatric patients one year old and above.

The use and monitoring of anesthesia on pediatric patients can differ from its use on adults, according to research cited by Masimo. Maintaining an appropriate level of anesthesia is key to preventing anesthesia-related events and enabling faster recovery.

The PSi in SedLine, driven by its pediatric-specific engine, is uniquely suited to helping clinicians interpret the EEGs of this challenging population, according to the company.

In addition to the newly announced pediatric-specific signal processing when used on pediatric patients, Next Generation SedLine offers significant improvements over original SedLine, including:

  • A PSi with less susceptibility to electromyography (EMG) interference.
  • A Multitaper Density Spectral Array (DSA), which may enhance visibility of EEG features.

“Next Generation SedLine is doing for brain function monitoring what Masimo SET did for pulse oximetry,” said Joe Kiani, Founder and CEO of Masimo. “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.”

Next Generation SedLine has received FDA clearance for adults but is not currently indicated for pediatric patients in the USA.