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Ceribell receives FDA 510(k) clearance for Clarity algorithm

CeriBell (CBLL) announced that the U.S. Food and Drug Administration has granted 510(k) clearance for its next-generation Clarity algorithm to detect electrographic seizures in newborns pre-term and older. This clearance makes the Ceribell System the first and only AI-powered point-of-care electroencephalograph technology available to detect electrographic seizures in all ages of patients, from pre-term neonates through adults.

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