Ceribell Expands Seizure Detection Technology to Neonatal Care

Ceribell, a leader in rapid electroencephalography (EEG) and brain monitoring solutions, has received FDA 510(k) clearance for its Clarity seizure-detection algorithm in neonates, marking a significant expansion of its technology into critical neonatal care.

Breakthrough in Neonatal Seizure Detection

The newly cleared algorithm processes data captured by a specialized headcap equipped with EEG sensors to detect electrographic seizures in newborns, including premature infants. This development addresses a crucial need in neonatal intensive care units (NICUs), where subclinical seizures can often go undetected without continuous EEG monitoring.

"During our pilot, we learned that our physicians and nurses would like the FDA clearance to be even more specific, that it is cleared for preterm as well as term neonate because they are very protective of this vulnerable population," said Jane Chao, CEO of Ceribell, during the company's third-quarter earnings call.

Market Expansion and Growth Potential

Ceribell executives estimate that the neonatal and pediatric markets will add $400 million to the company's current $2 billion addressable market opportunity. This expansion comes on the heels of strong financial performance, with Ceribell reporting sales of $64.3 million for the first nine months of 2025, representing a 37% increase over the same period in 2024.

The company's growth strategy includes targeting approximately 280 children's hospitals, where it currently has limited presence due to its historical focus on adult care. Additionally, Ceribell plans to expand its technology into NICUs managed by its existing network of about 200 hospital clients.

Regulatory Milestones and Product Development

Ceribell's journey to neonatal care has been marked by a series of regulatory achievements:

• April 2025: FDA clearance for the seizure-detection algorithm in children aged one year and older
• 2023: 510(k) clearance for a headcap suitable for use in children
• October 2025: Updated FDA clearance specifying the headcap's use for infants, including newborns and preterm babies

These clearances align with the American Clinical Neurophysiology Society's updated guidelines supporting continuous EEG monitoring in high-risk neonates.

Ceribell's rapid expansion into neonatal and pediatric care represents a significant advancement in early seizure detection and management for the most vulnerable patients, potentially improving outcomes and reducing unnecessary treatments in acute care settings.