CeriBell received FDA 510(k) clearance for its next-generation Ceribell Clarity algorithm. Clarity detects electrographic seizures in patients ages one and older. The company says this makes it the first and only AI-powered point-of-care electroencephalography (EEG) system cleared to detect electrographic seizures in patients at that age and to fully cover the age range from one year old to adult.
Using the technology, clinicians can detect non-convulsive seizures in pediatric patients in real time. This supports rapid diagnosis and treatment to help prevent serious brain injury.
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CeriBell says Clarity now provides coverage across the largest age range ever addressed by a seizure detection technology. It offers hospitals a complete solution for detecting seizures, supported by a large-scale EEG database. Clarity works with the CeriBell EEG headbands, currently marketed for adults, but now available for patients of all ages.
This latest advancement marks another milestone for CeriBell, which last fall completed an initial public offering (IPO).
“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, 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.”
