Cognetivity Neurosciences registers Integrated Cognitive Assessment for regulatory approval as CE-marked medical device
19 Dec, 2019, 09:00 ET
- Regulatory approval will establish the company's first CE-marked product.
- CE marking allows sale of device for medical environments across Europe.
VANCOUVER, Dec. 19, 2019 /CNW/ - Cognetivity Neurosciences Ltd. (the "Company" or "Cognetivity") (CSE: CGN; FWB: 1UB; OTCQB: CGNSF) today announced the registration of its Integrated Cognitive Assessment (ICA) with the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for CE marking.
A major milestone for the company, CE marking demonstrates conformity with EU medical device safety and performance requirements and will enable the ICA to be sold as a diagnostic aid in the UK, throughout the European Economic Area (EEA) and in other jurisdictions that accept a CE mark.
A University of Cambridge spin-out, Cognetivity developed the ICA to address the global challenge of dementia and, specifically, the unmet need for a test sensitive enough to identify the earliest stages of cognitive impairment, when healthcare interventions are most effective. The ICA's iPad-based image categorisation task takes five minutes, shows an absence of learning effects, and demonstrates resistance to cultural, educational and linguistic bias. It is powered by advanced AI techniques, enabling improvements in detection accuracy over time, and geared towards seamless integration with existing electronic health record (EHR) systems.
"The scientific validity of our product has long since been established. CE marking signifies something more," explained Dr Sina Habibi, Cognetivity's CEO. "It is a declaration that our product is ready for use and – underpinned by the clinical trial data that supports our registration – certification that the ICA is effective when deployed in a medical environment.
"It's gratifying to have reached this important milestone in line with our plans for the year. It demonstrates our commitment to potential customers we are already in conversation with. What's more, it gives us confidence in our plans to attain regulatory approval in other jurisdictions, beginning with the USA and Canada.
"Next year, we plan to bring our CE-marked ICA to the NHS and beyond, and begin to help tackle the dementia crisis for clinicians, patients and their families."
About Cognetivity Neurosciences Ltd.
Cognetivity is a technology company developing a cognitive testing platform, the Integrated Cognitive Assessment (ICA) for use in medical, commercial and consumer environments. Cognetivity's ICA uses Artificial Intelligence and machine learning techniques to help detect the earliest signs of impairment by testing the performance of large areas of the brain, potentially allowing early diagnosis of dementia. Cognetivity aims to develop the ICA through ongoing clinical studies to the market in North America, Europe and elsewhere in the world.
For more information, please visit: www.cognetivity.com
ON BEHALF OF THE BOARD
Chief Executive Officer and Director
FORWARD LOOKING STATEMENTS:
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SOURCE Cognetivity Neurosciences Ltd
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