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.