Cognetivity Neurosciences announces regulatory approval of first CE-marked medical device
Vancouver, British Columbia, January 7, 2020 – Cognetivity Neurosciences Ltd. (the “Company” or “Cognetivity”) (CSE: CGN; FWB: 1UB; OTCQB: CGNSF) today confirmed that its Integrated Cognitive Assessment (ICA) software has been approved as a CE-marked medical device. The announcement follows Cognetivity’s registration of the ICA with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) last month and enables the ICA to be used clinically across Europe.
Powered by Artificial Intelligence, the ICA is designed for use as a diagnostic aid for dementia, a syndrome that represents a substantial and ever-increasing global health burden. According to the World Health Organisation (WHO), 50 million people have dementia worldwide, with around 10 million new cases each year, and the total number of dementia sufferers is expected to reach 150 million by 2050.
Regulatory approval grants the ICA a CE mark, demonstrating conformity with EU medical device safety and performance requirements. It permits the ICA to be sold as a medical product in the UK and throughout the European Economic Area (EEA), the population of which exceeds 500 million people, with one in five over the age of 65. As such, it represents a major milestone in the company’s development and paves the way for its plans to obtain regulatory approval in other jurisdictions, including the USA, Canada and China.
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.
The forward-looking information contained in this press release is made as of the date of this press release and, except as required by applicable law, the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking information, whether as a result of new information, future events or otherwise, except as may be required by law. By its very nature, such forward-looking information requires the Company to make assumptions that may not materialize or that may not be accurate. This forward-looking information is subject to known and unknown risks and uncertainties and other factors, which may cause actual results, levels of activity and achievements to differ materially from those expressed or implied by such information.