Neuronetrix today announced that it has received 510(k) clearance (K141316) from the United States Food and Drug Administration to market the COGNISION™ System for clinical use.
The COGNISION™ System is a portable device used to record electrical brainwaves from patients with neurological problems. The COGNISION™ tests include both standard electroencephalograms (EEG) as well as auditory event-related potentials (ERP). The device is easy-to-use and inexpensive enough to be used by private practice physicians in their office.
Tests like those performed by COGNISION™ are often used by physicians during the evaluation of neurological disorders such as Alzheimer’s disease, concussion, Schizophrenia, and ADHD. Neuronetrix will begin marketing the COGNISION™ System to Alzheimer’s and memory disorder clinics and to physician practices which specialize in age-related dementias. The market potential for wide-spread Alzheimer’s diagnostics is projected to exceed several hundred million dollars per year in the U.S.
Complicated EEG tests have traditionally been performed in hospital electrophysiology labs by highly trained specialists. With the FDA’s approval of COGNISION™, these tests can now be performed during routine office visits by primary care physicians.
“Mobile neurodiagnostic devices offer great promise to enhance the objective assessment of a patients’ cognitive and neurological status at the point of care. Neural markers closely tied to cognitive status can also accelerate drug development for a variety of brain disorders” says Dr. Murali Doraiswamy, a leading expert in neurocognitive disorders at the Duke Institute for Brain Sciences and a scientific advisor to Neuronetrix.
Neuronetrix has already been marketing the test for use in clinical trials and has established a large network of committed users. Onnit Labs for example used COGNISION™ in their clinical study on Alpha BRAIN and reported positive results reflected in the COGNISION™ data. Anavex Life Sciences is using the test to evaluate the effects of a novel therapy on Alzheimer’s patients. The system is also being used in university clinical research such as the HIV-associated Neurocognitive Disorders ((HAND) study being performed at the Quillen College of Medicine (https://clinicaltrials.gov/ct2/show/NCT02187796).
“The effects of several drug compounds have already been successfully evaluated in well-controlled clinical studies using COGNISION™. Now physicians will have access to that same technology in their own practices.” said Dr. Marco Cecchi, Director of Research and Clinical Affairs.