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BOSTON--(BUSINESS WIRE)--The cognitive science company, Cogstate today announced the commercial deployment of its Cognigram™ digital cognitive assessment system at the University of Notre Dame. This placement represents the first Cognigram system commercial implementation in the United States, following the recent FDA notification that the Company can begin marketing the system in the U.S.
BOSTON--(BUSINESS WIRE)--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.
Cogstate Ltd (ASX:CGS) is preparing to reveal details in connection with its 510(k) submission to the U.S. Food and Drug Administration (FDA) for the Cogstate COGNIGRAMTM System.
TORONTO, ON--(Marketwired - May 01, 2017) - In a live presentation, industry expert Dr. Jeffrey Wefel, Section Chief and Associate Professor, Section of Neuropsychology, Department of Neuro-Oncology at The University of Texas MD Anderson Cancer Center will discuss the role and relevance of cognitive endpoints in clinical trials to accelerate our understanding of cognitive dysfunction related to cancer and cancer treatments.
CogState Limited (ASX:CGS) specialises in the development and commercialisation of rapid, computerised tests of cognition (brain function).