NEW YORK (360Dx) – Cerebrotech Medical Systems said today that is has received CE marking for its intracranial fluids monitor, a bioimpedance spectroscopy device that detects changes and distribution of brain fluids associated with stroke.
Cerebrotech noted that recent data from clinical research has demonstrated that the device can detect fluid asymmetry between the left and right hemispheres induced by large-vessel ischemic strokes. In under a minute, the wireless, non-invasive device can recognize bioimpedance asymmetry signals associated with stroke in patients experiencing stroke symptoms, the firm said.
Cerebrotech said that it employs proprietary machine learning and artificial intelligence software to train its system to detect bioimpedance frequency response patterns associated with neurological conditions. The company noted that it 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.
Wade Smith, chairman of the firm's scientific advisory board and a professor of neurocritical care and stroke at the University of California San Francisco, said that "having access to a device that can give us this information rapidly has the potential to significantly change the clinical paradigm for emergency stroke care.”
Cerebrotech President and CEO Mitch Levinson said that receiving European regulatory clearance in an emergency stroke application "is a significant milestone for the company, and paves the path to commercialization.”