CeriBell has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its proprietary delirium monitoring solution.

The clearance further establishes the Ceribell system as an artificial intelligence (AI)-powered brain monitoring platform technology. It extends the benefits to a larger population of critically ill patients and provides additional info to help diagnose patients at risk for both seizures and delirium.

The company’s delirium monitoring solution continuously analyzes EEG segments and notifies clinicians when patterns associated with delirium are spotted to support more timely, reliable evaluation and continuous delirium monitoring. The company said this will let its system simultaneously support continuous seizure, electrographic status epilepticus (ESE), and bedside delirium monitoring.

Ceribell’s delirium algorithm was validated using EEG data and clinical assessments collected through rigorous prospective studies involving 225 adults aged 22 years or older in critical care environments. This validation underscores the algorithm’s reliability and real-world utility for continuous delirium monitoring in the critical care setting.

FDA clearance follows Ceribell’s initial receipt of a Breakthrough Device Designation for delirium monitoring in 2022. Ceribell has submitted a New Technology Add-on Payment (NTAP) application to the Centers for Medicare and Medicaid Services (CMS) for this new indication.

“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, Ph.D., 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.”

Last month, the company won FDA clearance for its next-gen Clarity algorithm to detect electrographic seizures in newborns pre-term and older.