Ceribell announces FDA grants clearance for next-gen Ceribell Clarity algorithm

CeriBell (CBLL) announced that the U.S. Food and Drug Administration, 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. 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. “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.”