BROSSARD, Quebec, Canada — Diagnos, Inc. announced that 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 the company’s 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 Diagnos to fully deliver its services to IRIS The Visual Group and to deploy the marketing strategy to address the Canadian optometry market.
The Benefits of AI-Powered Retinal Imaging
“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.
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