---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-001800"
form_type: "8-K"
ticker: "CBLL"
cik: "0001861107"
company_name: "Ceribell, Inc."
filed_at: "2026-01-05T23:59:59+00:00"
generated_at: "2026-05-16T11:42:52.560245+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Ceribell receives FDA Breakthrough Device Designation for LVO stroke detection system

## Summary
- FDA Breakthrough Device Designation granted for CeriBell's LVO stroke detection and monitoring solution.
- First-in-class point-of-care EEG technology using existing hardware and AI algorithm to interpret signals.
- Nearly 800,000 annual US strokes; LVO strokes cause 62% of post-stroke dependence and 96% of mortalities.
- Designation supports potential expedited development; follows recent 510(k) clearances for Clarity and delirium screening.
- Targets in-hospital stroke patients, where detection and treatment delays lead to 3x higher mortality.

## SEC filing metadata
- accession: 0001193125-26-001800
- form_type: 8-K
- ticker: CBLL
- cik: 0001861107
- company_name: Ceribell, Inc.
- filed_at: 2026-01-05T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861107/000119312526001800/0001193125-26-001800-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861107/000119312526001800/cbll-20260105.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-001800
- JSON: https://secwatch.observer/filing/0001193125-26-001800.json
- Plain text: https://secwatch.observer/filing/0001193125-26-001800.txt

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