FDA Clears iSchemaView's Rapid Imaging Platform for Use in Selecting Acute Stroke Patients for Thrombectomy

 

January 15, 2019—iSchemaView announced that the FDA has cleared the company's Rapid neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy. Specifically, this additional clearance means that Rapid CT perfusion and Rapid MR perfusion can be used to aid in the selection of acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery for a thrombectomy procedure.

The Rapid cerebrovascular imaging software has a broad FDA clearance and has been clinically validated in more than 10 major trials.

Additionally, the Rapid platform was used as the exclusive imaging tool to select patients in two landmark stroke trials (DAWN and DEFUSE 3) that were published in The New England Journal of Medicine. Results of these studies helped change the American Heart Association and Canadian Heart and Stroke Foundation stroke guidelines to include CT perfusion and MRI perfusion, stated iSchemaView.

 

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