regulatory
confidence high
sentiment positive
materiality 0.70
InspireMD receives CE Mark approval for CGuard Prime EPS under EU MDR
InspireMD, Inc.
- 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.
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