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

DIAGNOS Receives Health Canada Medical Device Licence for --> Accessibility: Skip TopNav English French DIAGNOS Receives Health Canada Medical Device Licence for CARA System, Bringing AI-Assisted Retinal Image Analysis to Canadian Optometrists July 27, 2026 15:20 ET | Source: DIAGNOS Inc. DIAGNOS Inc. 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. CARA System technology integrates AI-powered analysis modules within a single clinician-controlled workflow: CARA-AMDdetect – Age-related macular degeneration detection CARA-DR – Diabetic retinopathy detection CARA-MVA – Retinal microvascular analysis CARA-Enhancement – Advanced retinal image enhancement CARA-CWS - Clinician WorkSpace for annotations By 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. Regulatory compliance update CARA 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 DIAGNOS DIAGNOS 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 i