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Cognivue, Inc. Receives Medical Device Establishment License from Health Canada


Victor, NY - December 22.  Cognivue, Inc. announces today that Cognivue™ Advanced® has received a Medical Device Establishment License (MDEL) from Health Canada, paving the way for the first fully-computerized test of cognitive function to be implemented in various healthcare settings across Canada. Cognivue is a world-class neuroscience company focusing on human cognitive function and mental health. The Cognivue device and technology is based on years of research that uses adaptive psychophysics to focus on cortical information processing by testing key cognitive domains. Cognivue technology significantly improves the ability of healthcare providers to implement a personalized assessment of cognitive function in a wide variety of care settings.

“Health Canada approval is a meaningful expansion of Cognivue’s presence, which until now has been focused on the United States,” says Tom O’Neill, President and CEO of Cognivue, Inc. “As a company, Cognivue is experiencing tremendous growth in a number of clinical practice areas. Additionally, we are collaborating with pharmaceutical and medical device industries as well as national recognized professional institutions, organizations, and advocates on joint clinical research opportunities. These types of partnerships will enable us to generate additional clinical data that further supports the use of Cognivue as a reliable and sensitive alternative to traditional cognitive screening methods. Our team is excited to now offer similar opportunities to potential customers and collaborators throughout Canada.”

Fred Ma, MD, PhD, who serves as Cognivue’s Senior Vice President and Chief Medical Officer, is encouraged by the opportunity to bring Cognivue technology to Canadian patients and clinicians. “Cognitive impairment is increasingly common in North America. We are seeing troubling trends related to post-COVID-19 syndrome, including what has been identified and referred to as ‘brain fog’, as well as numerous other clinical scenarios that drive a need for cognitive screening. We are in a unique situation where we are introducing Cognivue’s reliable cognitive assessment tool to the Canadian market right at the time where we can make a significant and meaningful impact.”

Cognivue technology objectively, quantitatively, and reliably identifies changes in cognitive function that could be indicative of an impairment that may be treated or managed by a healthcare professional. Unlike traditional paper and pencil cognitive screening methods, Cognivue assessment tools are:

  • Personalized: Assesses all cognitive domains with a highly sensitive test that is supported by the science of adaptive psychophysics.1
  • Consistent: Calibrated the same across all devices, ensuring consistency and retest reliability while eliminating human error in administering and scoring the test.1
  • User-friendly: Patient administered, producing a report that is easy to understand and communicate, with clinically meaningful correlations within key cognitive domains. Cognivue developed the first FDA-cleared computerized test of cognitive function. It is based on 15 years of research focusing on early detection of late-life cognitive decline (LLCD) and dementia.

Based on the same FDA-cleared technology, Cognivue has expanded its product offerings and now features a user-friendly portable device. Cognivue’s portfolio of products includes Cognivue Advanced, Cognivue Clarity® and Cognivue Thrive®, each uniquely developed to meet the varying needs of diverse clinical and research settings.

For more information, please visit

© 2021 Cognivue, Inc. Cognivue Advanced, Cognivue Clarity, and Cognivue Thrive should be considered adjunctive tools for evaluating cognitive function, not a stand-alone diagnostic tools. Clinical contextualization is required.


1. Cahn-Hidalgo D, Estes PW, Benabou R. Validity, reliability, and psychometric properties of a computerized, cognitive assessment test (Cognivue®). World J Psychiatry. 2020 Jan 19;10(1):1-11. doi: 10.5498/wjp.v10.i1.1. PMID: 31956523; PMCID: PMC6928378.

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