DIAGNOS Receives Health Canada Medical Device Licence for CARA System, Bringing AI-Assisted Retinal Image Analysis to Canadian Optometrists

Skip to Content News Archives Economy Energy Oil & Gas Renewables Electric Vehicles Mining Commodities Agriculture Real Estate Mortgages Mortgage Rates Finance Banking Insurance Fintech Cryptocurrency Work Wealth Smart Money Wealth Management Investor Personal Finance Family Finance Retirement Taxes High Net Worth FP Comment Executive Women Puzzmo Newsletters Financial Times Business Essentials More Innovation Information Technology FP500 Podcasts Small Business Lives Told Tails Told Shopping Financial Post Store Obituaries Place a Notice Advertising Advertising With Us Advertising Solutions Postmedia Ad Manager Sponsorship Requests Classifieds Place a Classifieds ad Working Profile Settings My Subscriptions Saved Articles My Offers Newsletters Customer Service FAQ News Economy Energy Mining Real Estate Finance Work Wealth Investor FP Comment Executive Women Puzzmo Newsletters Financial Times Business Essentials This advertisement has not loaded yet, but your article continues below.HomeGlobeNewswireThis section is The content in this section is supplied by GlobeNewswire for the purposes of distributing press releases on behalf of its clients. Postmedia has not reviewed the content. by GlobeNewswire DIAGNOS Receives Health Canada Medical Device Licence for CARA System, Bringing AI-Assisted Retinal Image Analysis to Canadian OptometristsAuthor of the article: You can save this article by registering for free here. Or sign-in if you have an account.BROSSARD, Quebec, July 27, 2026 (GLOBE NEWSWIRE) — Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a Corporation dedicated to the early detection of eye-related health using Artificial Intelligence (AI) techniques, is pleased to announce that, on July 23, 2026, it has received a Health Canada Medical Device Licence authorizing the commercialization of its CARA System in Canada.THIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman, and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.SUBSCRIBE TO UNLOCK MORE ARTICLESSubscribe now to read the latest news in your city and across Canada.Exclusive articles from Barbara Shecter, Joe O'Connor, Gabriel Friedman and others.Daily content from Financial Times, the world's leading global business publication.Unlimited online access to read articles from Financial Post, National Post and 15 news sites across Canada with one account.National Post ePaper, an electronic replica of the print edition to view on any device, share and comment on.Daily puzzles, including the New York Times Crossword.REGISTER / SIGN IN TO UNLOCK MORE ARTICLESCreate an account or sign in to continue with your reading experience.Access articles from across Canada with one account.Share your thoughts and join the conversation in the comments.Enjoy additional articles per month.Get email updates from your favourite authors.THIS ARTICLE IS FREE TO READ REGISTER TO UNLOCK.Create an account or sign in to continue with your reading experience.Access articles from across Canada with one accountShare your thoughts and join the conversation in the commentsEnjoy additional articles per monthGet email updates from your favourite authorsSign In or Create an AccountCARA System technology integrates AI-powered analysis modules within a single clinician-controlled workflow:CARA-AMDdetect – Age-related macular degeneration detectionCARA-DR – Diabetic retinopathy detectionCARA-MVA – Retinal microvascular analysisCARA-Enhancement – Advanced retinal image enhancementCARA-CWS – Clinician WorkSpace for annotationsGet the latest headlines, breaking news and columns.By signing up you consent to receive the above newsletter from Postmedia Network Inc.A welcome email is on its way. If you don't see it, please check your junk folder.The next issue of Top Stories will soon be in your inbox.We encountered an issue signing you up. Please try againBy combining image enhancement, explainable AI findings, fundus indicators and retinal vascular analytics, CARA helps clinicians unlock more clinically relevant information from every fundus photograph while ensuring that the optometrist remains in full control of every clinical decision.To our knowledge, CARA is one the first Canadian AI-retinal image analysis platform developed specifically for the Optometry sector to be granted a Class II medical device licence by Health Canada. This authorization allows us to fully deliver our services to IRIS The Visual Group (refer to announcement dated June 7, 2022) and to deploy our marketing strategy to address the Canadian optometry market.Nowadays, retina of the eye photography is routinely incorporated into optometry clinical workflows practices from both independent optometry practices and major eye care networks. Using advanced image enhancement and explainable artificial intelligence, CARA System uses every pixel of a fundus photograph to provide the optometrist with objective analytical insights related to retinal conditions that may not have been readily apparent.“For more than a decade, DIAGNOS has been working with AI for retinal image analysis through collaborations with clinicians and healthcare organizations around the world, driven by one mission – to help prevent avoidable blindness,” said André Larente, President and Chief Executive Officer of DIAGNOS.““Health Canada’s authorization of the CARA System is an important achievement not only for DIAGNOS, but also for Quebec’s innovation ecosystem,” said Philippe Couillard, chairman of the board of directors of DIAGNOS. “Successfully developing artificial intelligence for regulated medical devices requires scientific excellence, clinical rigor and exceptional perseverance. I am proud that Quebec-based companies can develop world-class medical technologies, meet one of the world’s most demanding regulatory standards, and compete successfully on the international stage.”“We are excited to bring CARA System to Canadian optometrists, unlocking the full clinical value of every fundus image through explainable AI. CARA System transforms routinely acquired retinal images into deeper clinical insights while ensuring clinicians remain at the center of every clinical decision,” said Yves-Stephane Couture, Chief Operating Officer of DIAGNOS.This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.Regulatory compliance updateCARA System is by nature a medical device which, in most markets, requires proper local regulatory commercialization authorization. Meeting regulatory compliance for medical devices ensures public safety. Management focus remains obtaining regulatory commercialization clearance for CARA System from the Saudi Arabia Food & Drug Authority (SFDA) and the United States Food and Drug Administration (US-FDA).Saudi Arabia: As stated in the Management Discussion and Analysis report (MD&A) dated June 11, 2026, available on www.diagnos.com and www.sedarplus.com, DIAGNOS formally submitted CARA System for marketing approval with the SFDA. Since then, the Corporation is addressing additional queries received from the SFDA. USA: As stated in MD&A dated June 11, 2026, available on www.diagnos.com and www.sedarplus.com, the legacy version of CARA, as a Medical Image Management and Processing System, remains cleared for commercialization in the U.S. With the help of our U.S. based regulatory consultant, our goal is to be able to submit the commercialization application of CARA System to the FDA before the end of September 2026.About DIAGNOSDIAGNOS is a publicly traded Canadian corporation dedicated to early detection of certain critical eye-related health problems. By leveraging Artificial Intelligence, DIAGNOS aims to provide more information to healthcare clinicians to enhance diagnostic accuracy, streamline workflows, and improve patient outcomes on a global scale.Additional information is available at www.diagnos.com and www.sedarplus.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 publicly 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 DIAGNOS Inc. Tel: 450-678-8882 ext. 224 alarente@diagnos.caNotice for the Postmedia NetworkThis website uses cookies to personalize your content (including ads), and allows us to analyze our traffic. Read more about cookies here. By continuing to use our site, you agree to our Terms of Use and Privacy Policy.