Masimo Announces CE Mark for Next Generation SedLine ® Brain Function Monitoring for Pediatric Use

Wednesday, Mar 06, 2019

Masimo today announced CE Mark for next-generation SedLine ® brain function monitoring for pediatric patients (ages 1-18 years). With this authorization, the benefits of next-generation SedLine technology are available to all patients aged one year or older in countries requiring CE marking. SedLine monitoring of brain function allows clinicians to assess the state of the brain under anesthesia through bilateral data acquisition and treatment of four EEG signal leads.

SedLine uses a pediatric signal processing engine to improve the performance of the Masimo-treated EEG parameter, the Optimized Patient State Index (PSi), when monitoring pediatric patients aged one to one. year and more. The use and monitoring of anesthesia in pediatric patients may differ from its use in adults. 1-2 It is critical to maintain an appropriate level of anesthesia to prevent anesthesia-related events and allow for faster recovery. 3 The SedLine PSi Index, driven by its pediatric motor, is ideally designed to help clinicians interpret the EEGs of this challenging population.

In addition to the latest signal processing specifically for pediatric patients, the next-generation SedLine technology offers significant improvements over the original SedLine, such as:

  • PSi with reduced sensitivity to electromyography (EMG) interference.
  • A "multitaper" Density Spectral Array (DSA) matrix, which can improve the visibility of the characteristics of the EEG.

Joe Kiani, founder and CEO of Masimo, said, "The next-generation SedLine technology offers in brain function monitoring what Masimo SET ® offers in pulse oximetry. We believe that the next-generation SedLine technology is the best and most advanced method for monitoring the depth of sedation, which is crucial for the adequate anesthesia of patients with particularly complex brains. We are pleased that his benefits are now available to young patients whose brains are particularly delicate and to whom Masimo has always demonstrated his commitment. "

The new generation SedLine technology has been approved by the FDA for use by adults, but is not currently approved for pediatric patients in the United States.



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