Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy.
With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute stroke patients with known occlusions of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure.
IschemaView touted its Rapid system as the only imaging platform approved for selecting stroke patients for clot removal.
“This FDA clearance confirms Rapid as the de facto standard in neuroimaging, not only for the automated analysis of brain images derived from CT and MRI, but now for the diagnosis and treatment of stroke. The new clearance will particularly benefit smaller community hospitals and the patients they serve. Because Rapid enables stroke treatment decisions that are based on intuitive and easily interpretable real-time views of brain perfusion, physicians will quickly and easily be able to determine which patients can be treated locally and which require urgent transfer to thrombectomy centers — bolstering the capabilities of smaller hospitals and therefore improving patient care,” CEO Don Listwin said in a press release.