Ceribell Expands Seizure-Detection Technology Into Neonatal and Pediatric Care

Ceribell is broadening its clinical reach after securing multiple FDA 510(k) clearances that authorize its Clarity seizure-detection algorithm and EEG headcaps for use in infants and children. The latest approval allows the algorithm to be used in newborns, complementing earlier clearance for patients aged one year and older. The system analyzes EEG data collected through a headcap or headband to identify electrographic and subclinical seizures that standard monitoring may miss.

Recent guideline updates from the American Clinical Neurophysiology Society support continuous EEG use in high-risk neonates, strengthening the case for Ceribell’s technology. The company has also advanced its pediatric hardware portfolio, including infant-specific headcaps cleared in 2023 and October 2025.

With evidence showing earlier seizure detection and reduced unnecessary treatment, Ceribell plans to expand into NICUs and children’s hospitals. This strategy could unlock an estimated $400 million market, adding to its existing $2 billion opportunity.

02-12-2025