secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2024-01-31T23:59:59+00:00
Accession:  0001493152-24-004411
Event type: regulatory
Sentiment:  positive
Materiality: 0.65
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224004411/0001493152-24-004411-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315224004411/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-004411

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