Ceribell wins FDA nod for algorithm to detect pediatric seizures

Ceribell has received FDA 510(k) clearance to expand the use of its Clarity algorithm for detecting electrographic seizures in children aged one year and older. This update builds on its previously cleared EEG headbands, now enabling real-time, bedside seizure detection in pediatric neurological emergencies. The Clarity algorithm, paired with Ceribell’s portable EEG system, aims to reduce diagnosis time and prevent brain injury in critically ill children. Previously, the algorithm was only cleared for patients 18 and older. The company plans to launch the pediatric feature soon, further positioning its platform as a faster alternative to conventional EEG systems used mainly in outpatient epilepsy diagnosis. Despite concerns over U.S.-China tariffs, which recently caused a sharp stock drop, Ceribell remains insulated through Q3 2025 due to existing inventory. Analysts view the tariff impact as temporary and potentially mitigated by relocating production. Ceribell’s main competitors include Natus Medical and Nihon Kohden.

28-04-2025