Cognivue, Inc announced that its fully-computerized test of cognitive function has received a Medical Device Establishment License (MDEL) from Health Canada. The approval “paves the way for Cognivue’s technology to be implemented across the healthcare spectrum in Canada, including in audiology, optometry, neurology, retail pharmacy, employee wellness, and general practice,” according to the company’s announcement.
Cognivue is a neuroscience company focusing on human cognitive function and mental health. Its technologies are designed to give healthcare providers tools for cognitive evaluation and diagnosis. The digital system is engineered to “eliminate testing bias and variability while establishing cognitive baselines and offering a concurrent monitoring vehicle for the evaluation and treatment of cognitive issues over time.”
“Health Canada approval accelerates Cognivue’s geographic expansion, which until now has been focused on the United States with the first FDA-cleared computerized test of cognitive function,” said Tom O’Neill, President and CEO of Cognivue, Inc. “The company is experiencing tremendous growth in a number of clinical practice areas. We are also collaborating with partners in the pharmaceutical and medical device industries, as well as prominent professional institutions, organizations, and advocates on joint clinical research opportunities. These partnerships will enable us to generate additional clinical data that further supports Cognivue as a reliable and sensitive alternative to traditional cognitive screening methods. Our team is excited to offer similar opportunities to potential customers and collaborators throughout Canada.”
The Cognivue device and technologies are based on years of research that uses adaptive psychophysics to focus on cortical information processing by testing key cognitive domains. This significantly improves the ability of healthcare providers to implement a personalized assessment of cognitive function.
“Cognitive impairment is increasingly common in North America,” said Fred Ma, MD, PhD, Senior Vice President and Chief Medical Officer of Cognivue, Inc. “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. Access to Cognivue’s reliable cognitive assessment tool will have a significant and meaningful impact for Canadian patients and physicians.”