FDA Clears Ceribell’s AI-Powered EEG as First Device for Continuous Delirium Monitoring

Ceribell has received FDA 510(k) clearance for the world’s first continuous, AI-powered delirium monitoring solution—significantly expanding its EEG platform beyond seizure detection. Delirium affects up to 80% of ventilated ICU patients, yet is frequently missed due to subjective, manual assessments. This clearance enables Ceribell to deliver the first objective, real-time monitoring tool for a condition closely tied to higher mortality, long-term cognitive decline, and substantial healthcare costs.

The new solution transforms Ceribell’s headband EEG system into a broader AI-driven brain monitoring platform. The algorithm continuously analyzes EEG patterns associated with delirium and alerts clinicians when concerning activity appears—essentially providing a neurological “vital sign” for the brain. Validated in prospective studies involving 225 critical care patients, the technology is designed to catch both hyperactive and hypoactive forms of delirium, the latter of which is often overlooked. Experts note that this continuous, automated approach could dramatically improve detection rates compared to intermittent bedside assessments.

The clearance also strengthens Ceribell’s strategic position, as nearly half of ICU patients who experience seizures also develop peri-ictal delirium. By offering both seizure and delirium monitoring in one system, Ceribell provides clinicians with a unified view of neurological status, supporting faster, more informed decisions. CEO Jane Chao, PhD, said the development brings Ceribell closer to making EEG a standard vital sign in critical care. The company has already submitted a New Technology Add-on Payment (NTAP) application to CMS to support hospital reimbursement and broader adoption.