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.
免責聲明：投資有風險，本文並非投資建議，以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請，作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考，不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證，投資者應自行研究並在投資前尋求專業建議。