Ceribell, Inc., has received FDA 510(k) clearance for its delirium monitoring solution, the first FDA-cleared device for delirium screening and monitoring.
The approval positions the Ceribell System as an AI-driven brain monitoring platform, supporting a wider group of critically ill patients and providing clinicians with data to detect both seizures and delirium.
Delirium is a serious condition in critically ill patients, linked to higher mortality, longer hospital stays, increased costs, and long-term cognitive impairment.
Traditional detection relies on intermittent bedside checks, which can vary between clinicians. Ceribell offers continuous, objective monitoring, alerting clinicians to EEG patterns associated with delirium for real-time evaluation and intervention.
The delirium algorithm was validated in prospective studies of 225 adults in critical care, demonstrating reliability. Ceribell has also applied for the New Technology Add-on Payment (NTAP) for this indication.
Delirium affects 31% of ICU patients and up to 80% of ventilated patients. It is often missed, particularly in hypoactive cases.
There is also a strong link between seizures and delirium, with many ICU patients showing peri-ictal delirium or epileptiform discharges.
By combining seizure and delirium monitoring, the Ceribell System provides comprehensive neurological insights to support faster, informed clinical decisions, expanding EEG technology to improve brain care in critical care settings.
