Neurology
Ceribell Delirium Monitor System
Ceribell, Inc.
FDA
FDA-cleared AI medical device
Software that analyzes segments of electroencephalogram signal for patterns associated with delirium and notifies clinicians, intended to aid screening and monitoring of delirium alongside clinical assessment in adult critical-care patients.
FDA Submission Metadata
- Submission number
- K251936
- Decision date
- December 2025
- FDA panel
- Neurology
- Product code
- NCG
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA