"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 CEO, 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."