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What You Should Know: 

– Ceribell, Inc. today announced that the U.S. FDA has granted 510(k) clearance for its next-generation Clarity® algorithm. 

– The FDA clearance makes the Ceribell System the first and only AI-powered point-of-care electroencephalography (EEG) technology available to detect electrographic seizures in all patients, from pre-term neonates through adults.

Closing a Critical Unmet Need in Neonatal Care

The FDA clearance for the Clarity® algorithm to detect electrographic seizures in newborns pre-term and older addresses a severe diagnostic gap in neonatal intensive care units (NICUs). Despite being the most common neurological emergency in newborns], research suggests that up to 90% of neonatal seizures go undetected without continuous EEG monitoring].

This lack of timely EEG administration and continuous monitoring often results in unnecessary patient transfers, delayed treatment, and poor outcomes. The stakes are high: high-risk newborns who seize for more than 13 minutes in an hour may have an 8-fold increased chance of poor outcomes, including mortality and long-term disability.

The AI-Powered Solution for All Ages

Ceribell’s system is the first and only AI-powered point-of-care EEG technology cleared to detect electrographic seizures across the entire age spectrum, from pre-term neonates through adults. The 510(k) clearance for the Clarity® algorithm was supported by the largest known validation dataset ever used for a neonatal seizure detection system, including EEG data from more than 700 patients.

By combining proprietary algorithms with purpose-built hardware (including a previously cleared headcap optimized for neonates), the Ceribell System empowers clinicians to detect non-convulsive seizures in real time, supporting rapid diagnosis and treatment to help prevent serious brain injury.