Cerebrotech's Visor Device Receives FDA Clearance
January 10, 2018—Cerebrotech Medical Systems, Inc. recently announced US Food and Drug Administration clearance for the company's Visor device, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use of the device as an aid in the assessment of fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. Cerebrotech advised that it is continuing clinical studies to further validate the device for identifying specific brain pathologies including stroke, trauma, swelling, and others.
According to the company, Visor is a noninvasive bioimpedance spectroscopy device that detects changes and distribution of cerebral fluids using Cerebrotech's Volumetric Impedance Phase-shift Spectroscopy (VIPS) technology.
Cerebrotech explained that the Visor device detects fluid asymmetry as a change in the ratio of bioimpedance measurements on each of the two sides. The company has developed a machine learning system to optimize its algorithms to recognize and differentiate between the bioimpedance profiles of various brain pathologies.
Visor is designed to be portable, fast, and accurate. Utilizing data captured by the device, unique algorithms can be developed that can help physicians to better detect and diagnose a wide range of neurological conditions, improving outcomes for patients while reducing overall health care costs, the company stated.
Stroke neurologist Andrei Alexandrov, MD, commented in the company's announcement, "Clearance of a simple, easy-to-use device that can provide accurate information about cerebral fluids in 30 seconds is an important development. 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." Dr. Alexandrov is Semmes-Murphey Professor and Chairman, Department of Neurology, University of Tennessee Center for Health Science in Memphis, Tennessee.
In November 2017, the company announced European CE Mark approval of the device for the measurement of bioimpedance asymmetry associated with stroke. In July 2017, findings from the VITAL study evaluating the company’s VIPS technology for emergency stroke patients were presented by Christopher P. Kellner, MD, at the 14th annual meeting of the Society of NeuroInterventional Surgery in Colorado Springs, Colorado.