secwatch.observer — SEC 8-K summary
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Issuer:     CapsoVision, Inc (CV)
CIK:        0001378325
Form:       8-K
Filed at:   2025-11-10T23:59:59+00:00
Accession:  0001378325-25-000031
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CapsoVision files FDA Breakthrough Device application for pancreatic cancer screening capsule
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1378325/000137832525000031/0001378325-25-000031-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1378325/000137832525000031/cv-20251110.htm
  HTML page:      https://secwatch.observer/filing/0001378325-25-000031

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer