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Press Release

Cogstate Receives Positive FDA Notification Regarding Medical Device Regulatory Submission

Cogstate Ltd
Posted on: 27 Jul 17

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 COGNIGRAM™ 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 COGNIGRAM™ 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 COGNIGRAM™ system can be used to assess cognition on a single occasion or cognitive change over periodic assessments. Performance on the COGNIGRAM™ 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 COGNIGRAMtechnology 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 COGNIGRAMsystem available to U.S. health systems, hospitals, physician practices, elder care organizations, schools and sports teams.

About Cogstate

Cogstate Ltd (ASX:CGS) is a leading science and technology solutions provider dedicated to optimizing the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides enabling technologies and professional services for higher quality neuropsychological assessments and is a pioneer in commercializing rapid, reliable and sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; elite sporting organizations and military; physicians and patients; renowned academic institutions and public-private partnerships. For more information visit

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Last updated on: 27/07/2017

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