Ceribell receives FDA 510(k) clearance for Clarity algorithm to detect seizures in neonates

Ceribell, Inc.

FDA clearance covers use of Clarity algorithm for electrographic seizure detection in newborns preterm and older through adults, the first AI-powered point-of-care EEG for all ages.
Clearance supported by EEG data from over 700 patients, the largest known validation dataset for a neonatal seizure detection system.
Approximately 9% of NICU patients may have seizures, but up to 90% go undetected without EEG monitoring, per the release.
Ceribell previously received 510(k) clearance for a headcap optimized for the neonatal population.
CEO Jane Chao cited the clearance as expanding availability of rapid, AI-powered neurological monitoring to more patients.

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