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Medical Devices / Submissions and Approvals

IschemaView Gains Expanded Clearance for Neuroimager

Jan. 18, 2019

The FDA handed medical imaging developer IschemaView expanded clearance for its Rapid neuroimaging platform.

The imaging platform is intended for use in selecting stroke patients that are expected to benefit from endovascular thrombectomy, which treats strokes by pulling blood clots out of arteries.

The company said the Rapid system is the only imaging platform currently approved for selecting stroke patients for blood clot removal.

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