---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-292140"
form_type: "8-K"
ticker: "CBLL"
cik: "0001861107"
company_name: "Ceribell, Inc."
filed_at: "2025-11-24T23:59:59+00:00"
generated_at: "2026-05-16T17:22:09.545127+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 Clarity algorithm to detect seizures in neonates

## Summary
- FDA clearance covers use of Clarity algorithm for electrographic seizure detection in newborns preterm and older through adults, the first AI-powered point-of-care EEG for all ages.
- Clearance supported by EEG data from over 700 patients, the largest known validation dataset for a neonatal seizure detection system.
- Approximately 9% of NICU patients may have seizures, but up to 90% go undetected without EEG monitoring, per the release.
- Ceribell previously received 510(k) clearance for a headcap optimized for the neonatal population.
- CEO Jane Chao cited the clearance as expanding availability of rapid, AI-powered neurological monitoring to more patients.

## SEC filing metadata
- accession: 0001193125-25-292140
- form_type: 8-K
- ticker: CBLL
- cik: 0001861107
- company_name: Ceribell, Inc.
- filed_at: 2025-11-24T23:59:59+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/1861107/000119312525292140/0001193125-25-292140-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861107/000119312525292140/cbll-20251124.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-292140
- JSON: https://secwatch.observer/filing/0001193125-25-292140.json
- Plain text: https://secwatch.observer/filing/0001193125-25-292140.txt

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