Clearance makes the platform the first and only FDA-cleared delirium screening and monitoring device. It comes on the heels of FDA clearance for a next-generation algorithm for monitoring seizures in neonatal patients last month.
Sunnyvale, California-based Ceribell says it further establishes its system as an AI-powered brain monitoring platform technology. Clearance extends its benefits to more critically ill patients and provides additional information to assist in diagnosing patients at risk for both seizures and delirium.
The company already got the FDA’s green light for its seizure algorithm in pediatric patients earlier this year. That milestone followed the completion of an initial public offering (IPO) in 2024.
Ceribell’s system utilizes point-of-care electroencephalography (EEG), analyzing segments and notifying clinicians when patterns associated with delirium are detected. It supports more timely, reliable evaluation and continuous monitoring. The system can now support continuous seizure, electrographic status epilepticus (ESE) and delirium monitoring at the bedside.
“Delirium has been under recognized and under treated in critically ill patients for far too long, despite its strong association with poor outcomes,” said Jane Chao, co-founder and CEO of Ceribell. “With this FDA clearance, Ceribell is proud to expand EEG technology into delirium care, bringing the first objective, continuous monitoring solution to clinicians who urgently need better tools to support these vulnerable patients. We expect to finalize our go-to-market strategy in the near future, and look forward to leveraging our existing commercial footprint and reputation as the category leader in AI-based neuro monitoring to bring this transformational technology to patients in need. This is another big step towards our mission of making EEG a new vital sign for better brain care.”
