Ceribell Expands Seizure Detection Capabilities with FDA Clearance for Neonates

Ceribell, a leading medical technology company, has received FDA clearance for its Clarity algorithm to detect electrographic seizures in preterm infants, expanding its capabilities across all age groups. This development marks a significant advancement in neonatal care and seizure management.

Breakthrough in Neonatal Seizure Detection

Ceribell's latest FDA clearance allows for the use of its artificial intelligence-powered electroencephalography (EEG) technology in detecting seizures in preterm infants. This advancement addresses a critical need in neonatal intensive care units (NICUs), where research suggests that up to 9% of newborns may experience seizures, with as many as 90% of cases potentially going undetected due to the absence of physical symptoms.

Jane Chao, Ph.D., Ceribell's co-founder and CEO, emphasized the importance of this development: "Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long-term development and well-being. Every newborn deserves timely and accessible seizure detection, without the delays and transfers that too often put outcomes at risk."

Expanding Market Opportunities

The FDA clearance opens up new market opportunities for Ceribell. The company estimates that the neonatal and pediatric markets will add $400 million to its current $2 billion addressable market opportunity. Ceribell plans to target approximately 280 children's hospitals and expand its presence in NICUs managed by existing clients.

Ceribell's financial performance reflects its growth trajectory, with sales of $64.3 million reported for the first nine months of 2025, representing a 37% increase compared to the same period in 2024. The company's recent initial public offering (IPO) in October 2024 raised $180.3 million, further solidifying its position in the medical technology sector.

Technical Advancements and Clinical Impact

Ceribell's point-of-care EEG system, which first received FDA clearance in 2017 for identifying suspected seizure activity, has evolved to include specialized components for different age groups. The system now incorporates a headcap with EEG sensors designed specifically for infants, including newborns and preterm babies.

The American Clinical Neurophysiology Society updated its guidelines on continuous EEG monitoring last year, supporting the use of this technology in neonates at high risk for seizures. Ceribell's system addresses the limitations of conventional EEG systems by providing rapid diagnosis and continuous monitoring capabilities crucial in acute care settings.

Dr. Chao highlighted the clinical impact of their technology, stating that Ceribell has case studies demonstrating early seizure detection and the prevention of unnecessary treatments. These outcomes are expected to be pivotal in persuading more NICUs to adopt Ceribell's technology.