BROSSARD, Quebec, April 23, 2019 (GLOBE NEWSWIRE) -- DIAGNOS Inc. (“DIAGNOS”, “the Corporation” or “we”) (TSX Venture: ADK) (DGNOF), a leader in early detection of critical health issues through the use of its FLAIRE platform based on Artificial Intelligence (AI), announces today that its quality management system continues to fully comply with the requirements of ISO 13485:2016 - Medical devices quality standard.
As part of the requirements for the commercialization of our flagship product CARA from Health Canada, the Food and Drug Agency in the US and CE in Europe, DIAGNOS must undergo thorough statutory annual quality compliance audits, such as the Medical Device Single Audit Program (MDSAP). The MDSAP is a comprehensive approach to quality system auditing and includes the development of an international coalition of countries devoted to pooling resources, technology, and services to enhance the safety and oversight of medical devices worldwide.
“I would like to take this opportunity to personally thank each of our employees for their hard work and commitment to the quality of our products. Our clients expect our healthcare solutions to perform well while being safe and DIAGNOS is able to meet their expectations”, said Mr. André Larente, President of DIAGNOS.
DIAGNOS is a publicly-traded Canadian corporation with a mission of early detection of critical health issues through the use of its Artificial Intelligence (“AI”) tool CARA (Computer Assisted Retina Analysis). CARA is a tele-ophthalmology platform that integrates with existing equipment (hardware and software) and processes at the point of care. CARA’s Artificial Intelligence image enhancement algorithms make standard retinal images sharper, clearer and easier to read. CARA is accessible securely over the internet, and is compatible with all recognized image formats and brands of fundus cameras, and is EMR compatible. CARA is a cost-effective tool for screening large numbers of patients in real-time and has been cleared for commercialization by several regulatory authorities such as Health Canada, the U.S. Food and Drug Administration and the European Union.
For further information about this press release, please contact:
|Mr. André Larente, President|
|Tel: 450-678-8882 ext. 224|
This news release contains forward-looking information. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in these statements. DIAGNOS disclaims any intention or obligation to publically update or revise any forward-looking information, whether as a result of new information, future events or otherwise. The forward-looking information contained in this news release is expressly qualified by this cautionary statement.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.