Ceribell receives FDA 510(k) clearance for first delirium monitoring solution

Ceribell, Inc.

FDA cleared Ceribell's EEG-based delirium screening and monitoring system for critically ill patients.
Algorithm validated in prospective study of 225 adults in critical care; continuous monitoring at bedside.
Delirium affects ~31% of ICU patients and up to 80% of mechanically ventilated; associated with higher mortality and dementia risk.
Ceribell has submitted NTAP application to CMS for the new indication; leverages existing commercial footprint.
CEO Jane Chao expects to finalize go-to-market strategy soon; builds on prior Breakthrough Device Designation (2022).

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