CeriBell announced 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.
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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.
The company said that the early detection of seizures represents a critical unmet need in neonatal care. Its EEG headcap designed specifically for the neonatal population, paired with the next-generation algorithm, can help with detection. Combining the algorithms with purpose-built hardware enables the detection of non-convulsive seizures in real time. This supports rapid diagnosis and treatment to help prevent serious brain injury.
CeriBell supported its latest FDA clearance with EEG data from more than 700 patients. It says that represented the largest known validation dataset ever used for a neonatal seizure detection system.
“Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long-term development and well-being,” said Jane Chao, co-founder and CEO of Ceribell. “This FDA clearance enables us to further expand availability of Ceribell’s rapid, AI-powered neurological monitoring technology and serve more patients in need. Every newborn deserves timely and accessible seizure detection, without the delays and transfers that too often put outcomes at risk.”
