---
schema_version: "secwatch.filing_event.v1"
accession: "0001378325-25-000043"
form_type: "8-K"
ticker: "CV"
cik: "0001378325"
company_name: "CapsoVision, Inc"
filed_at: "2025-12-29T23:59:59+00:00"
generated_at: "2026-05-16T12:05:19.761685+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# CapsoVision submits 510(k) to FDA for AI-assisted reading module for CapsoCam Plus

## Summary
- Submitted 510(k) to FDA for proprietary AI-assisted module for CapsoCam Plus capsule endoscopy system.
- AI module designed to improve detection of clinically significant pathology and reduce clinician review time.
- Company plans to commence U.S. commercialization following FDA clearance.
- CapsoVision claims it is the only capsule endoscopy company with in-house AI core competency.
- Cloud-based architecture eliminates need for on-site servers, reducing cost and IT maintenance.

## SEC filing metadata
- accession: 0001378325-25-000043
- form_type: 8-K
- ticker: CV
- cik: 0001378325
- company_name: CapsoVision, Inc
- filed_at: 2025-12-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1378325/000137832525000043/0001378325-25-000043-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1378325/000137832525000043/cv-20251229.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001378325-25-000043
- JSON: https://secwatch.observer/filing/0001378325-25-000043.json
- Plain text: https://secwatch.observer/filing/0001378325-25-000043.txt

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