CE Mark Approval for Cerebrotech's Bioimpedance Monitor to Detect Asymmetry Associated With Stroke
November 29, 2017—Cerebrotech Medical Systems, Inc., which is focused on the development of a portable brain bioimpedance monitor, announced that the company's Intracranial Fluids Monitor received European CE Mark approval for detection of bioimpedance asymmetry associated with stroke. The device was previously approved for an indication to detect changes to intracranial fluids in patients at risk for edema. The device is not yet cleared for sale in the United States, advised the company.
According to the company, the Intracranial Fluids Monitor is a noninvasive bioimpedance spectroscopy device designed to detect changes and distribution of brain fluids. Recent data from Cerebrotech-sponsored clinical research have demonstrated that the device can detect fluid asymmetry between the left and right hemispheres induced by large vessel ischemic strokes. In < 1 minute, the device can recognize bioimpedance asymmetry signals associated with stroke in patients experiencing stroke symptoms.
Cerebrotech noted that it uses machine learning and artificial intelligence software to train the system to detect bioimpedance frequency response patterns associated with neurological conditions. The company has plans to train the Intracranial Fluids Monitor to detect a variety of disease states, including stroke, cerebral edema, traumatic brain injury, hydrocephalus, concussion, and brain tumors.