Masimo's SedLine Brain Function Monitor Sensor Scores FDA Approval For Pediatric Use

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The FDA has FDA cleared Masimo Corp's MASI SedLine brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. 

  • 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. 
  • Related: Needham Upgrades Masimo To Buy, With Price Target Of $205.
  • 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 complete picture of the brain.
  • Dr. Cristina Verdú of Hospital Universitario La Paz, Madrid, Spain, said, "in addition to monitoring anesthetic depth, it allows us to detect warning signs such as asymmetries or seizures; it tells us what is happening to the child's brain."
  • Price Action: MASI shares are up 0.21% at $153.54 during the market session on the last check Monday.
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