CeriBell (CBLL) said Tuesday its Clarity algorithm has received 510(k) clearance from the US Food and Drug Administration for the detection of electrographic seizures in patients aged at least one.
The company said that based on its assessment, the algorithm now provides coverage across the widest age range addressed by a seizure detection technology, allowing hospitals to detect electrographic seizures in pediatric and adult patients alike.
The algorithm is designed for use with the company's electroencephalography headbands that are currently marketed for adults and cleared for use in patients of all ages, the company said.
CeriBell said its artificial intelligence-powered point-of-care electroencephalography system enables prompt bedside neurological evaluation and provides real-time insights into patient condition.
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