The approval will enable the medical technology company to expand the potential benefits of SedLine, which is equipped with its advanced signal processing technology
Masimo SedLine Brain Function Monitoring. (Credit: Business Wire)
Masimo has received the US Food and Drug Administration (FDA) clearance for its SedLine brain function monitoring and SedLine Pediatric EEG Sensor for pediatric patients.
The approval will enable the medical technology company to expand the potential benefits of SedLine, which is equipped with Masimo’s advanced signal processing technology, to all the patients aged one year or above in the US.
SedLine is designed to help clinicians to monitor brain activity bilaterally by processing electroencephalogram (EEG) signals that come from Masimo’s four-lead SedLine EEG sensors.
The FDA approval will facilitate Masimo’s bilateral brain activity monitoring to children 1 to 17 years old, along with specially sized pediatric sensors which can be easily placed on small pediatric foreheads.
Masimo founder and chief executive officer Joe Kiani said: “SedLine is achieving for brain function monitoring what Masimo SET did for pulse oximetry.
“We believe SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging and the youngest brains are appropriately anesthetized. We are proud to be able to bring its benefits to children in the United States.”
Brain activity monitoring in children under anesthesia is different compared to that of adults. In order to prevent anaesthesia-related events and enable faster recovery, the doctor has to maintain an appropriate depth of anesthesia.
SedLine provides clinicians with a complete picture of the brain to help them in monitoring anesthesia depth on children. It features both the display of EEG signals and the Multitaper Density Spectral Array (DSA) from both sides of the brain.
Dr. Cristina Verdú of Hospital Universitario La Paz, Madrid, Spain said: “SedLine is an easy window into a child’s electroencephalogram. It helps us to personalize sedoanalgesia. Now, we can choose the appropriate dose according to its effects, not just according to weight or age.
“But 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.”
In September last year, Masimo announced that their EMMA Portable Capnograph is effective for monitoring mechanically ventilated preterm infants.