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InspireMD shared its Q3 2026 results and announced FDA approval for its CGuard Prime device.

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FDA approval lets InspireMD offer CGuard Prime for TCAR in the U.S. and reaches over 35,000 more procedures yearly. U.S. sales are expected in the fourth quarter, and its separate CAS version still needs testing and another FDA filing.

NSPR · InspireMD, Inc.

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This gives InspireMD a route back to U.S. sales and access to more procedures. The company expects sales to begin in the fourth quarter, so the added reach has not yet appeared in reported U.S. sales. International revenue also rose 9% from the same quarter last year. A separate CAS version still needs final testing and another FDA filing before a possible 2027 relaunch. InspireMD reported $19.2 million in cash and marketable securities, but gave no earlier figure or spending rate.

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