Cerebrotech Visor™ Receives FDA Clearance

Cerebrotech Visor™ Receives FDA Clearance

PR Newswire (paid press release):

PLEASANTON, Calif., Jan. 4, 2018 /PRNewswire/ — Cerebrotech Medical Systems, an innovative medical device company developing neurotechnology solutions, has received clearance from the Food and Drug Administration, or FDA, for the Cerebrotech Visor, previously known as the CMS-5000™ Intracranial Fluids Monitor™. The clearance includes a broad indication for use as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company is continuing its clinical studies to further validate the device for identifying specific brain pathologies including stroke, trauma, swelling and others.

“We understand the challenges facing medical professionals who need to quickly assess patients with neurologic symptoms. The Cerebrotech Visor is designed to be portable, fast and accurate. Utilizing the vast amount of data captured by our proprietary Cerebrotech Visor, our mission is to develop unique algorithms that can help physicians to better detect and diagnose a wide range of neurological conditions, improving outcomes for patients while reducing overall healthcare costs,” remarked Cerebrotech’s Medical System’s Chief Executive Officer, Mitch Levinson. “This FDA clearance, is an important milestone for the company on our path to achieving that mission.”

The Visor is a noninvasive bioimpedance spectroscopy device that detects changes and distribution of cerebral fluids using its proprietary technology called Volumetric Impedance Phase-shift Spectroscopy (VIPS™). Many neurologic conditions create a difference in fluid volumes between the brain’s right and left hemispheres. The device detects that fluid asymmetry as a change in the ratio of bioimpedance measurements on each of the two sides.  The company has developed a proprietary machine learning system to optimize its algorithms to recognize and differentiate between the bioimpedance profiles of various brain pathologies. In Europe, the device is CE marked for the measurement of bioimpedance asymmetry associated with stroke.

“Clearance of a simple, easy-to-use device that can provide accurate information about cerebral fluids in 30 seconds is an important development,” said stroke neurologist Andrei Alexandrov, M.D., Semmes-Murphey Professor and Chairman, Department of Neurology, University of Tennessee Center for Health Science. “During neurologic assessment, presence and magnitude of fluid asymmetry is a critical piece of information that will help us understand and evaluate our patients. I see tremendous potential for this technology for a large cross-section of patients with neurologic symptoms and various conditions.”

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 and investigating 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.

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SOURCE Cerebrotech Medical Systems

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