CeriBell gets FDA nod for neonate seizure detection algorithm

CeriBell (Nasdaq:CBLL) announced today that it received FDA 510(k) clearance for its next-generation Clarity algorithm.

The new algorithm detects electrographic seizures in newborns pre-term and older. Clearance makes the Ceribell System the first and only AI-powered point-of-care electroencephalography (EEG) technology available to detect electrographic seizures in all ages of patients, from pre-term neonates through adults, according to a news release.

Sunnyvale, California–based CeriBell already got the FDA’s green light for its algorithm in pediatric patients earlier this year. That milestone followed the completion of an initial public offering (IPO) in 2024.

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