Neurology
Ceribell Delirium Monitor System
Ceribell, Inc.
FDA-cleared AI medical device
Uses a patient's electroencephalograph (EEG) to provide an interpretation of the patient's neuropsychiatric condition. It is also used only as an assessment aid for a medical condition for which there exists other valid methods of diagnosis."
FDA Submission Metadata
- Submission number
- K251936
- Decision date
- December 2025
- FDA panel
- Neurology
- Product code
- NCG
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.