Cogstate receives positive FDA notification regarding medical device regulatory submission
July 27, 2017
Company to launch COGNIGRAMTM digital cognitive testing tool in U.S. healthcare market
Boston, MA – July 27, 2017: The cognitive science company, Cogstate today announced that its healthcare division has received notification from the U.S. Food and Drug Administration (FDA) that the Company’s 510(k) submission (K171658) for the COGNIGRAMTM cognitive assessment system has been reviewed by the Center for Devices and Radiological Health and found to meet the requirements of regulations 21 CFR 882.1470; Class II Exempt Medical Device. This notification allows the company to market the medical device for commercial distribution in the U.S.
The COGNIGRAMTM system is a digital cognitive assessment tool with self-administered assessment that can be completed both in-clinic and at-home. It is for prescription use, and is intended to aid healthcare professionals with an objective measurement of cognition for use in individuals aged 6 – 99 years old. The COGNIGRAMTM system can be used to assess cognition on a single occasion or cognitive change over periodic assessments. Performance on the COGNIGRAMTM system is unaffected by language, education, cultural background, or practice.
“After more than fifteen years of intense efforts in supporting academic research and pharmaceutical clinical trials around the world, Cogstate is excited to enter the U.S. market for cognitive assessment on the front lines of clinical practice,” commented Frank Cheng, President of Cogstate Healthcare. “We look forward to bringing the proven and widely-published COGNIGRAM technology into the healthcare ecosystem to benefit an exponentially larger pool of patients.”
Factors that may affect an individual’s cognition include the presence of mild cognitive impairment (MCI), Alzheimer’s disease, concussion, head injury, major depressive disorder, HIV related dementia, schizophrenia, attention deficit hyperactivity disorder (ADHD), multiple sclerosis, Parkinson’s disease, the effects of medication or surgery, as well as a variety of psychological states (e.g. stress, fatigue).
Cogstate will immediately make the COGNIGRAM system available to U.S. health systems, hospitals, physician practices, elder care organizations, schools and sports teams.
President, Cogstate Healthcare
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