RAPID Neuroimaging Cleared For Stroke Patient Selection

FDA has cleared an iSchemaView 510(k) for its RAPID neuroimaging platform for use in selecting stroke patients who are likely to benefit from endovascular thrombectomy (clot removal). The additional clearance allows RAPID CT-Perfusion and RAPID MR-Perfusion to be used by physicians to aid in the selection of acute stroke patients with known occlusion of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure, the company says. The RAPID platform was used for patient selection for two landmark stroke trials published in The New England Journal of Medicine, DAWN and DEFUSE 3, that treated patients up to twenty-four hours after onset. “The results of these studies changed the American Heart Association and American Stroke Association’s 2018 stroke guidelines to expand the stroke treatment window from six hours to 24 hours for eligible patients,” iSchemaView says.