DIAGNOS Successfully Completes ISO 13485 / MDSAP Surveillance Audit

Published on: January 14, 2020

BROSSARD, Quebec, Jan. 14, 2020 (GLOBE NEWSWIRE) — Diagnos Inc. (“DIAGNOS”, the “Corporation” or ”We”) (TSX Venture: ADK) (OTCQB: 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 applicable regulatory requirements for medical devices.

As part of the requirements for the commercialization of our flagship product CARA from Health Canada, the Food and Drug Agency in the US (FDA) 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 management systems 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 also announcing that Dr. Jean-François Yale has accepted a new role as scientific advisor to the Corporation and, effective today, Dr. Yale is no longer a member of the board of directors of the Corporation.


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. CARA complies with local regulations, is FDA cleared for commercialization in the United States of America is Health Canada licensed for commercialization in Canada and is CE marking compliant in Europe.

Additional information is available at www.diagnos.ca and www.sedar.com

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.

For further information, please contact:

Mr. André Larente, President


Tel: 450-678-8882 ext. 224

[email protected]

Healthcare Life Science Technology