CeriBell has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-gen Clarity algorithm to detect electrographic seizures in newborns pre-term and older.

The FDA nod makes the Ceribell system the first and only artificial intelligence (AI)-powered point-of-care electroencephalography (EEG) tech to spot electrographic seizures in all ages of patients, from pre-term neonates through adults.

The company’s 510(k) was supported by EEG data from over 700 patients, which it said is the largest known dataset used for a neonatal seizure detection system. Ceribell also previously received 510(k) clearance for a headcap optimized for the neonatal population.

The system combines proprietary algorithms with purpose-built hardware so clinicians can detect non-convulsive seizures in neonatal patients in real-time. This supports rapid diagnosis and treatment to help prevent serious brain injury.

“Seizures are the most common neurological emergency in newborns, and protecting these fragile brains is essential to their long-term development and well-being,” said Jane Chao, Ph.D., co-founder and CEO of Ceribell. “This FDA clearance enables us to further expand availability of Ceribell’s rapid, AI-powered neurological monitoring technology and serve more patients in need. Every newborn deserves timely and accessible seizure detection, without the delays and transfers that too often put outcomes at risk.”

“Ceribell’s easy-to-use, AI-powered point-of-care EEG helps address a critical gap in neonatal care by enabling prompt bedside neurological assessment and delivering real-time insights about each patient’s condition,” added Dr. Janene Fuerch, Medical Director of Neonatal ECMO at Stanford Children’s Hospital. “I have seen firsthand that many NICUs do not have 24/7 access to EEG. There is a clear need for faster, more accessible tools to evaluate brain activity at the bedside—especially in those critical first hours of life.”

In May, the company earned full FedRAMP (Federal Risk and Authorization Management Program) High authorization from the U.S. government for its point-of-care EEG system.