Masimo Gets 510(k) Clearance for Pediatric Indication for Brain Scanners

March 3, 2022

Irvine, Calif.-based Masimo has received the FDA’s 510(k) clearance for its SedLine brain function monitor for pediatric patients and its SedLine pediatric electroencephalogram (EEG) sensor.

The devices, which monitor brain activity from both sides of the brain, are cleared for use on patients aged one and older. The pediatric sensors are sized for easier application on smaller foreheads.

In addition to monitoring anesthetic depth, the SedLine system also allows clinicians to detect warning signs, such as asymmetries or seizures, the company said.

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