There is only one piece of advice: be patient, and document every step in the development process you use.
On July 23, 2026, Brossard-based DIAGNOS received a Health Canada Medical Device Licence authorizing the commercialization of its CARA System in Canada. The platform brings AI-assisted fundus image analysis to optometrists through modules for age-related macular degeneration detection, diabetic retinopathy detection, retinal microvascular analysis and retinal image enhancement, plus a clinician workspace for annotations. All of it sits inside a single workflow in which the optometrist stays in control of every clinical decision.
DIAGNOS says CARA is, to its knowledge, one of the first Canadian AI platforms for retinal image analysis for optometrists to be granted a Class II medical device licence by Health Canada. The licence also allows the company to fully deliver its services to IRIS The Visual Group and to start addressing the wider Canadian optometry market. Chairman Philippe Couillard called the authorization an important achievement for Quebec's innovation ecosystem, pointing to the scientific excellence, clinical rigor and perseverance that regulated medical AI demands.
We spoke with André Larente, President and Chief Executive Officer of DIAGNOS, about the problem behind CARA, AI in optometry, a long road through the regulator and what comes next. More on the company is available at diagnos.ca.
What was the original problem that led you to start building CARA, and what gap in retinal screening were you trying to close? #
The original problem we saw was that retinal analysis was not standardized across all optometrists. To close this gap we built an AI tool to analyse retinal images, based on over 500,000 patient data that we collected in many countries around the world.
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Can you walk us through what CARA actually does and how AI-assisted retinal image analysis fits into an optometrist's existing workflow? #
The beauty of our system is that it does not disrupt the actual business process in a store. The patient journey in the store is the same as before. CARA is used when the patient takes imaging information, just as they do every day.
Health Canada's licence for a diagnostic AI tool is a demanding process. What did that journey look like from your side, and what did it take to get CARA across the line? #
Health Canada was a very long process, although the timelines they provide on their website were not respected. It took about 1 year and 3 months to finally have a face-to-face meeting to explain the risks associated with our submission.
I brought the director of the optometry school in Montreal with me to explain that the risk was very minimal or 0. They did not understand our solution until this meeting happened, and we received our approval 40 days later.
Why was it important to build CARA specifically for a regulated clinical setting rather than as a more general consumer product? #
This was not our choice. The AI market started very strong, but after all the bad publicity worldwide, government reacted by making any AI medical application mandatory. So we had to comply with this change.
How do you see CARA changing the way optometrists screen patients day to day? #
CARA does not change the way an optometrist cares for the patient, it helps them ensure they don't miss pathologies in the early stages.
What has the response been like so far from the people who will actually be using CARA in practice? #
The optometrists who use CARA really appreciate the precision it gives them when making a diagnosis. Some of the tests cannot be made by a human due to the complexity of the images.
Where do you want to take DIAGNOS and CARA from here, now that this licence is in hand? #
Our program is to get our Saudi Arabia licence (we did) and our US FDA licence for the US market. By partnering with the right organizations worldwide, we will be able to address a much larger footprint.
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What advice would you give to other founders trying to bring an AI medical device through a regulatory process like this one? #
There is only one piece of advice: be patient, and document every step in the development process you use.
That advice is earned. Larente describes fifteen months of waiting before a single face-to-face meeting, an approval that arrived 40 days after the regulator finally understood the solution, and a market that changed its rules while DIAGNOS was building.
The result is a tool that leaves the optometrist's routine untouched and aims to make sure early pathologies are not missed. More about the company is at diagnos.ca.
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