---
schema_version: "secwatch.filing_event.v1"
accession: "0001641172-25-014986"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2025-06-13T23:59:59+00:00"
generated_at: "2026-05-19T07:55:32.716694+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# InspireMD receives CE Mark approval for CGuard Prime EPS under EU MDR

## Summary
- CE Mark approval under European Medical Device Regulation (MDR) for CGuard Prime Embolic Prevention System.
- Product designed with MicroNet mesh to reduce embolic events and prevent stroke.
- Approval clears path for commercial launch in current CE-marked served markets.
- Same platform intended for US launch later in 2025, subject to FDA approval.
- CEO Marvin Slosman highlights regulatory milestone and next-generation platform advancement.

## SEC filing metadata
- accession: 0001641172-25-014986
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2025-06-13T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000164117225014986/0001641172-25-014986-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000164117225014986/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001641172-25-014986
- JSON: https://secwatch.observer/filing/0001641172-25-014986.json
- Plain text: https://secwatch.observer/filing/0001641172-25-014986.txt

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