CeriBell Receives FDA Clearance for Algorithm Detecting Electrographic Seizures in Neonates-December 2024-www.financetom.com

CeriBell Receives FDA Clearance for Algorithm Detecting Electrographic Seizures in Neonates

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CeriBell Receives FDA Clearance for Algorithm Detecting Electrographic Seizures in Neonates

Nov 24, 2025 5:56 AM

08:41 AM EST, 11/24/2025 (MT Newswires) -- CeriBell ( CBLL ) said Monday that it received 510(k) clearance from the US Food and Drug Administration for its next-generation Clarity algorithm that aims to detect electrographic seizures in newborns pre-term and older.

CeriBell ( CBLL ) said its system is the first AI-powered point-of-care electroencephalography technology available that detects electrographic seizures in all ages, from pre-term neonates to adults.

The clearance was supported by electroencephalography data from over 700 patients, the company said.

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