DIAGNOS Advances Regulatory Strategy with US FDA Submission for CARA System

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Postmedia has not reviewed the content. by GlobeNewswire DIAGNOS Advances Regulatory Strategy with US FDA Submission for CARA SystemAuthor of the article:BROSSARD, Quebec, Sept. 28, 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 it has submitted a Section 513(g) Request for Information to the U.S. Food and Drug Administration (“FDA”) regarding the classification and applicable regulatory requirements for its CARA System.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 AccountThis advertisement has not loaded yet, but your article continues below.The submission follows DIAGNOS’ FDA Pre-Submission filing. DIAGNOS filed this submission to address a specific recommendation received from the FDA. This represents another important step in DIAGNOS’ U.S. regulatory and commercial strategy for the CARA System.Get 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 againCARA System is the logical progression of DIAGNOS’ existing Medical Image Management and Processing System (MIMPS). The new device combines an updated deterministic retinal image enhancement algorithm (CARA-Enhancement), a dedicated interface for clinician-lead annotations related to retinal conditions, and AI-powered analytic modules that support optometrists in the analysis of retinal images.:CARA-AMDdetect – Age-related macular degeneration indicators detectionCARA-DR – Diabetic retinopathy indicators detectionCARA-MVA – Retinal microvascular analysisBy combining image enhancement, supplementary AI findings, and retinal image and retina microvascular analytics, CARA System helps clinicians unlock more clinically relevant information from every fundus photograph while ensuring that the optometrist remains in full control of every clinical decision.This advertisement has not loaded yet, but your article continues below.“This submission represents another milestone in our strategy to bring CARA System to the U.S. market,” said André Larente, President of DIAGNOS. Building on its established license in Canada, for the optometry market, DIAGNOS is pursuing a separate regulatory pathway in the U.S. to access a market of approximately 49,500 optometrists, seeing strong commercial potential in both markets for its AI-assisted solution designed to streamline clinical workflows, ensure diagnostic consistency, and support early detection in everyday optometric practice.About DIAGNOSDIAGNOS is a public Canadian corporation dedicated to the early detection of critical eye-related health problems. DIAGNOS manufactures CARA System, a software platform which assists health specialists in the detection of retinal eye pathologies. CARA System is currently licensed for commercialization in Canada and Saudi Arabia. By developing innovative products based on AI technologies, DIAGNOS’ solutions provide healthcare clinicians with valuable information that refines diagnostic accuracy, streamlines workflows, and improves patient outcomes.This advertisement has not loaded yet.This advertisement has not loaded yet, but your article continues below.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.caThis advertisement has not loaded yet.Notice 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.