Submitted by kBLASTER Team on
by David A. Mann for Louisville Business First
Louisville-based Neuronetrix Inc. has received U.S. Food and Drug Administration 510(k) clearance for a medical device that measures brain activity.
The device, called the Cognision, has been in development for more than 10 years. It collects data that can be used to evaluate several neurological and cognitive disorders, including Alzheimer's disease and concussions, said Neuronetrix CEO K.C. Fadem. The company believes that the market for widespread Alzheimer's diagnostics is particularly strong. I wrote about a clinical trial of the device about this time last year.
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