The breakthrough nod covers the use of the stroke detection monitor in the hospital setting. Sunnyvale, California-based Ceribell based its first-in-class offering on its existing hardware. The platform uses an AI-based algorithm to interpret EEG signals for early detection of LVO stroke.

According to a news release, LVO strokes are medical emergencies that carry disproportionately higher morbidity and mortality compared to non-LVO, ischemic stroke. Timely detection and access can lead to significant health benefits over the patient’s lifetime.

Ceribell said the breakthrough nod marks the latest milestone in its effort to expand the uses of its point-of-care EEG brain monitoring technology. It comes on the heels of FDA clearance for a delirium monitoring solution, which came a month after clearance for a next-generation algorithm for monitoring seizures in neonatal patients.