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

InspireMD, Inc.

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.

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