(RTTNews) - CeriBell, Inc. (CBLL) announces that the U.S. FDA has granted 510(k) clearance for its next-generation Clarity algorithm to detect electrographic seizures in preterm neonates through adults.
Seizures are the most common neurological emergency in newborns, yet up to 90% go undetected without EEG monitoring. High-risk neonates who spend more than 13 minutes seizing in an hour face an eight-fold increased risk of poor outcomes, including mortality and long-term disability.
The Clarity algorithm, integrated into the Ceribell System, is the first and only FDA-cleared seizure detection technology covering all ages. It enables rapid, bedside detection of non-convulsive seizures, supporting timely diagnosis and treatment to help prevent serious brain injury. The clearance was supported by EEG data from more than 700 patients, the largest known validation dataset for neonatal seizure detection.
Ceribell previously received clearance for a neonatal headcap optimized for neonatal monitoring. By combining proprietary AI-powered algorithms with purpose-built hardware, the Ceribell System provides clinicians with real-time neurological insights at the bedside.
CEO Jane Chao, said, "Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long-term development and well-being. This FDA clearance enables us to expand availability of Ceribell's rapid, AI-powered neurological monitoring technology and serve more patients in need."
CBLL has traded in the range of $10.01 to $32.75. The stock is currently trading at $15.23, down 0.23%.
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