Medical technology company Neuronetrix has obtained 510(k) approval from the US Food and Drug Administration for its portable device Cognision System, for clinical use.
The Cognision System has been developed to record electrical brainwaves from patients with neurological problems.
Neuronetrix scientific advisor and Duke Institute for Brain Sciences neurocognitive disorders expert Dr Murali Doraiswamy said: "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."
Designed for use by private practice physicians in their office, the Cognision tests include both standard electroencephalograms (EEG) and auditory event-related potentials (ERP).
Physicians can use Cognision during the evaluation of neurological disorders, including Alzheimer’s disease, concussion, Schizophrenia, and ADHD.
According to Neuronetrix, Onnit Labs used Cognision in their clinical study on Alpha BRAIN and reported positive results reflected in the Cognision data, while Anavex Life Sciences is using the test to assess the effects of a therapy on Alzheimer’s patients.
The system will also be used in university clinical research such as the HIV-associated Neurocognitive Disorders (HAND) study being performed at the Quillen College of Medicine.
Image: The Cognision System. Photo: courtesy of Neuronetrix/ PRNewswire.