---
schema_version: "secwatch.filing_event.v1"
accession: "0001378325-25-000031"
form_type: "8-K"
ticker: "CV"
cik: "0001378325"
company_name: "CapsoVision, Inc"
filed_at: "2025-11-10T23:59:59+00:00"
generated_at: "2026-05-16T22:18:44.205037+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# CapsoVision files FDA Breakthrough Device application for pancreatic cancer screening capsule

## Summary
- Submitted BDD application to FDA on Nov 6, 2025 for CapsoCam UGI capsule to detect early-stage pancreatic ductal adenocarcinoma.
- If granted, the designation would enable accelerated development and closer FDA collaboration on clinical studies.
- CapsoCam UGI is a non-invasive, pill-shaped camera with panoramic imaging to visualize duodenal papilla changes.
- Pancreatic cancer has 8-10% five-year survival rate; no non-invasive screening exists for the general population.

## SEC filing metadata
- accession: 0001378325-25-000031
- form_type: 8-K
- ticker: CV
- cik: 0001378325
- company_name: CapsoVision, Inc
- filed_at: 2025-11-10T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1378325/000137832525000031/0001378325-25-000031-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1378325/000137832525000031/cv-20251110.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001378325-25-000031
- JSON: https://secwatch.observer/filing/0001378325-25-000031.json
- Plain text: https://secwatch.observer/filing/0001378325-25-000031.txt

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