Masimo has made a name for itself as a prolific purveyor of noninvasive patient monitoring technologies, from the SET pulse oximeter to the recently CE-marked Rainbow SuperSensor, which continuously collects readings of 12 health parameters.
The latest addition to Masimo’s collection is a new iteration of an existing device, after the FDA expanded its clearance of the SedLine brain function monitoring system and sensors.
The SedLine system was originally cleared by the FDA in 2004, followed by several technological updates in the ensuing years. Each of those versions were given the agency’s go-ahead to be used to monitor brain activity while adult patients are under anesthesia.
The new clearance, however, broadens the reach of the SedLine system to patients as young as 1 year old in the U.S.—albeit with the same indication to help maintain an appropriate depth of anesthesia and spot any adverse reactions to the sedative.
With the FDA’s OK, Masimo has introduced a version of the SedLine system specially designed for pediatric cases. The noninvasive electrode sensors, for example, are smaller than those used on adult patients to better fit children’s foreheads.
The four-lead sensors pick up electroencephalogram (EEG) signals from both sides of the brain, then transfer those readings to the SedLine monitor. From there, physicians can keep an eye on brain function to ensure that anesthetized patients are not only at the right level of sedation, but also aren’t at risk of experiencing seizures or any other reactions to the anesthesia.
“SedLine is achieving for brain function monitoring what Masimo SET did for pulse oximetry,” Joe Kiani, founder and CEO of Masimo, said in a statement. “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.”
RELATED: FDA clears wireless patient monitoring devices from Masimo, MyHomeDoc
The SedLine system was originally developed by Physiometrix, a small devicemaker that had once been purchased by Hospira. In early 2010, Hospira sold off its brain function monitoring business to SEDLine, which was ultimately acquired by Masimo, one of its financial backers, just a few months later.
Masimo’s last update to the system came in 2018 when it improved the “patient state index,” or the calculation of how anesthesia is affecting a patient’s brain function.
Additionally, at the end of 2021, the company shared results of a prospective study showing that using the SedLine technology to monitor brain activity may help identify adult patients at risk of developing anesthesia-related conditions not just during, but after surgical procedures. The study found a potential EEG-based marker for early identification of postoperative delirium, which has been linked to prolonged EEG burst suppression during general anesthesia.