NIHON KOHDEN INDIA PRIVATE LIMITED

FDA Clears Ceribell's AI Algorithm for Pediatric Seizure Detection in Patients as Young as One Year Old

- Ceribell has received FDA 510(k) clearance for its next-generation Clarity algorithm that can detect electrographic seizures in patients as young as one year old, becoming the first AI-powered point-of-care EEG system with this capability. - The technology combines a disposable flexible headband with a pocket-sized recorder to wirelessly transmit EEG signals, making continuous brain monitoring more accessible in various care settings and potentially reducing time to seizure detection. - Despite recent investor concerns about Chinese tariffs potentially reducing gross margins by 8-10 percentage points, Ceribell has contingency plans to relocate production to other countries within a year if necessary.