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November 27, 2018

InspireMD's CGuard Carotid EPS Approved in Australia

November 28, 2018—InspireMD, Inc. announced that Australia's Therapeutic Goods Administration approved the CGuard embolic prevention system (EPS) for the prevention of stroke caused by the treatment of carotid artery disease. The device is approved for commercial sale and reimbursement and will be launched in Australia immediately in collaboration with InspireMD’s local distribution partner, Diverse Devices Pty Ltd., of Sydney.

In 2013, InspireMD received European CE Mark approval for the self-expanding nitinol CGuard carotid EPS, which is based on the company’s MicroNet mesh protection platform technology that is also used for the treatment of myocardial infarction patients in InspireMD’s commercially available coronary MGuard and MGuard Prime EPS devices.

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November 28, 2018

FDA Announces Plans to Modernize 510(k) Program

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November 28, 2018

FDA Announces Plans to Modernize 510(k) Program

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