The FDA has cleared Neuronetrix’s portable device for the recording of electrical brainwaves in patients with neurological conditions such as Alzheimer’s disease, concussion, schizophrenia and ADHD.
The device, called the Cognision System, is designed to run brainwave tests such as EEGs and auditory event-related potentials (ERPs). Neuronetrix said the device allows doctors to run tests in their offices that used to be only available in a hospital setting.
“Mobile neurodiagnostic devices offer great promise to enhance the objective assessment of a patient’s 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,” said Dr. Murali Doraiswamy, a Neuronetrix scientific advisor and neurocognitive specialist at the Duke Institute for Brain Sciences.
Neuronetrix said the product is already on the market for use in clinical trials and research studies.
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, Neuronetrix’s director of research, in a statement.
