Masimo receives CE mark for SedLine monitoring in paediatric patients

5 March 2019 (Last Updated March 5th, 2019 10:17)

Masimo has secured a Conformité Européene (CE) mark for brain function monitoring device SedLine.

Masimo receives CE mark for SedLine monitoring in paediatric patients
SedLine allows clinicians to monitor the brain when a patient is under anaesthesia. Credit: Business Wire.

Masimo has secured a Conformité Européene (CE) mark for brain function monitoring device SedLine.

To be available for children aged one year and above, SedLine uses bilateral data acquisition and electroencephalogram (EEG) signals processing to observe brain activity when a patient is under anaesthesia.

The unit features a density spectral array (DSA) display that comprises left and right spectrograms representing the EEG on both sides of the brain.

“We believe next generation SedLine is the best and most advanced way to monitor depth of sedation.”

SedLine uses four simultaneous channels of frontal EEG waveforms and a paediatric-specific signal processing engine to deliver an enhanced patient state index (PSi). These will support clinicians to address anaesthesia-related differences between paediatrics and adults.

Masimo founder and CEO Joe Kiani said: “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 anesthetised.

“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.”

SedLine holds US Food and Drug Administration (FDA) clearance for adults but is yet to be indicated for paediatric patients in the country.

In September last year, the FDA cleared Masimo Rainbow Acoustic Monitoring (RAM) RAS-45 acoustic respiration sensor for infant and neonatal use.