---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-004411"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2024-01-31T23:59:59+00:00"
generated_at: "2026-06-06T13:15:02.818177+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# InspireMD Receives CE Mark Recertification Under EU MDR for CGuard Stent System

## Summary
- CE Mark recertification under EU's new Medical Device Regulation (MDR) obtained.
- CGuard EPS can continue to be marketed in existing EU territories.
- U.S. C-GUARDIANS IDE trial primary endpoint results expected mid-2024.
- Final module of PMA submission to FDA planned for second half of 2024.
- Potential U.S. approval of CGuard Prime EPS stent system in first half of 2025.

## SEC filing metadata
- accession: 0001493152-24-004411
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2024-01-31T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315224004411/0001493152-24-004411-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315224004411/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-004411
- JSON: https://secwatch.observer/filing/0001493152-24-004411.json
- Plain text: https://secwatch.observer/filing/0001493152-24-004411.txt

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