---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-312035"
form_type: "8-K"
ticker: "CBLL"
cik: "0001861107"
company_name: "Ceribell, Inc."
filed_at: "2025-12-09T23:59:59+00:00"
generated_at: "2026-05-16T13:50:14.284516+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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).

## SEC filing metadata
- accession: 0001193125-25-312035
- form_type: 8-K
- ticker: CBLL
- cik: 0001861107
- company_name: Ceribell, Inc.
- filed_at: 2025-12-09T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861107/000119312525312035/0001193125-25-312035-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861107/000119312525312035/cbll-20251209.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-312035
- JSON: https://secwatch.observer/filing/0001193125-25-312035.json
- Plain text: https://secwatch.observer/filing/0001193125-25-312035.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.