Next-gen brain function monitoring cleared by the FDA

2nd February 2018

Masimo

Enaie Azambuja

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Datasheet

Masimo has announced FDA clearance of Next Generation SedLine brain function monitoring. SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral acquisition and processing of four leads of electroencephalogram (EEG) signals. Next Generation SedLine features an enhanced signal processing engine, driving a variety of performance improvements and helping give clinicians a more complete picture of the brain.

Next Generation SedLine provides an enhanced Patient State Index (PSi) – a processed EEG parameter related to the effect of anesthetic agents – based on its enhanced signal processing engine.

In addition, Next Generation SedLine displays an enhanced, Multitaper Density Spectral Array (DSA), developed by Dr. Emery Brown, MD, PhD, and Dr. Patrick Purdon, PhD, Director and Associate Director, respectively, of the Neuroscience Statistics Research Lab at Massachusetts General Hospital.

The DSA represents activity in both sides of the brain. When displaying a Multitaper DSA, EEG data are transformed into the frequency domain, and may provide a better display of EEG features.

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is committed to innovation in the brain function monitoring space. With the improved performance offered by its enhanced signal processing capabilities, we expect Next Generation SedLine to impact brain function monitoring just as SET impacted pulse oximetry."

When used with the RD SedLine EEG sensor, Next Generation SedLine can be used simultaneously with O3 regional oximetry on the Root patient monitoring and connectivity platform for even more insight into a patient's brain. O3 may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.