PLEASANTON, Calif.--(BUSINESS WIRE)--Cerebrotech Medical Systems, an innovative medical device company focused on the development of a portable brain bioimpedance monitor, received CE (Conformité Européenne) Marking, the primary regulatory clearance required in European Union states and some other countries, for detection of bioimpedance asymmetry associated with stroke. This latest certification for Cerebrotech’s Intracranial Fluids Monitor (ICF) is in addition to the previous indication for use in detecting changes to intracranial fluids in patients at risk for edema.
The Intracranial Fluids Monitor is a non-invasive bioimpedance spectroscopy device designed to detect changes and distribution of brain fluids. Recent data from Cerebrotech’s sponsored 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 device can recognize bioimpedance asymmetry signals associated with stroke in patients experiencing stroke symptoms.
“Our ability to quickly assess and respond to strokes is critical to ensuring good outcomes for our patients,” said Wade Smith, MD, PhD, Daryl R. Gress Endowed Professor of Neurocritical Care and Stroke at University of California San Francisco, and Chairman of the company’s Scientific Advisory Board. “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.”
"European regulatory clearance in this emergency stroke application is a significant milestone for the company, and paves the path to commercialization,” said Mitch Levinson, President and CEO, Cerebrotech Medical Systems. “We are looking forward to advancing the state of stroke care with our wireless and non-invasive approach to intracranial monitoring.”
Cerebrotech employs proprietary 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. The device is not yet cleared for sale in the United States.
About Cerebrotech Medical Systems
Cerebrotech Medical Systems, Inc., is a venture capital-backed company dedicated to designing neurotechnology solutions to improve the care of brain-injured patients worldwide. The company is developing a portable, noninvasive neuro-monitoring device that allows for earlier detection of potentially life-threatening conditions such as large vessel occlusion stroke, cerebral edema, traumatic brain injury, and others. Founded in 2010 and based in Pleasanton, CA, Cerebrotech’s core intellectual property is licensed exclusively from the University of California at Berkeley. Cerebrotech is backed by Tri-Star Health Partners, a healthcare focused venture capital firm, Mountain Group Partners, a life sciences and technology focused venture capital firm, Neuro Technology Investors, a group of physician investors in the neuro space. For more information, visit www.cerebrotechmedical.com.