---
schema_version: "secwatch.filing_event.v1"
accession: "0001378325-26-000045"
form_type: "8-K"
ticker: "CV"
cik: "0001378325"
company_name: "CapsoVision, Inc"
filed_at: "2026-09-28T15:03:33+00:00"
generated_at: "2026-10-12T13:33:33.307391+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# CapsoVision wins FDA clearance for AI Highlights, its AI-assisted reading tool for CapsoCam Plus

## Summary
- FDA cleared AI Highlights on September 25, 2026; CapsoVision announced the clearance on September 28, 2026.
- Tool marks suspected abnormal lesions in small bowel capsule endoscopy studies for adults and pediatric patients over age two with suspected small bowel bleeding.
- Aims to cut physician review time; integrates with CapsoView review software and CapsoCloud workflows without a separate AI platform.
- AI Highlights launched internationally earlier in 2026, including the EU under Medical Device Regulation, per CEO Johnny Wang.
- Company notes the tool is not intended to replace gastroenterologists' diagnostic interpretation or histopathological sampling.

## SEC filing metadata
- accession: 0001378325-26-000045
- form_type: 8-K
- ticker: CV
- cik: 0001378325
- company_name: CapsoVision, Inc
- filed_at: 2026-09-28T15:03:33+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1378325/000137832526000045/0001378325-26-000045-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1378325/000137832526000045/cv-20260925.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001378325-26-000045
- JSON: https://secwatch.observer/filing/0001378325-26-000045.json
- Plain text: https://secwatch.observer/filing/0001378325-26-000045.txt

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