FDA clears Ceribell Clarity algorithm for neonatal seizure detection, expanding to all patient ages

Ceribell/Clarity Rapid-Response EEG

Ceribell received FDA 510(k) clearance for its Clarity algorithm for neonatal seizure detection in November 2025, making the Ceribell System the first and only AI-powered point-of-care EEG available to detect electrographic seizures in patients of all ages, from pre-term neonates through adults.

• Clearance supported by EEG data from more than 700 patients, the largest validation dataset ever used for a neonatal seizure detection system.
• Clarity algorithm reduces ICU stay by 4.1 days, door-to-EEG time by 19.4 hours, and severe disability at discharge by 18 percentage points.
• Neonatal seizure detection unlocks incremental market opportunities exceeding $1.5 billion.