CeriBell today announced that the FDA has granted 510(k) clearance for its next generation Ceribell Clarity algorithm for the detection of electrographic seizures in patients ages 1 and older. The company said this makes Ceribell the first and only AI-powered point-of-care EEG system cleared to detect electrographic seizures in children as young as 1 year old and to fully cover the age range from 1 year old to adult. Using Ceribell’s solution, clinicians will be able to detect non-convulsive seizures in pediatric patients in real time, supporting faster diagnosis and treatment to help prevent serious brain injury.
Based on Ceribell’s assessment, its Clarity algorithm now provides coverage across the largest age range ever addressed by a seizure detection technology. The pediatric clearance was supported by electroencephalography (EEG) data collected from more than 1,700 patients, which FDA data indicates is the largest validation dataset ever used for FDA clearance of a seizure detection system, reflecting the scale of Ceribell’s extensive EEG database and the rigor of its validation process and algorithm. The Clarity algorithm is designed to be used with the same Ceribell EEG headbands currently marketed for adults, which are cleared for use in patients of all ages.
"We believe this clearance will have a profound impact on the lives of critically ill children, who are particularly vulnerable to preventable brain injury," said Jane Chao, Ph.D., co-founder and CEO of Ceribell. "It is well understood that seizures can lead to poor clinical outcomes when not treated in a timely manner. Yet, until now, clinicians have never had access to point-of-care EEG with a seizure detection algorithm tailored specifically for pediatric patients as young as 1 year old. This breakthrough, which we expect to be commercially available soon, marks another important step toward our mission of making rapid EEG the standard of care for everyone."
Ceribell’s AI-powered point-of-care EEG helps fill this critical gap by enabling prompt bedside neurological assessment and providing real-time insights into a patient’s condition.
