DIAGNOS Secures Health Canada Licence for CARA AI-Driven Retinal Imaging System

Health Canada Approval Paves Way for CARA’s Canadian Market Launch

DIAGNOS Inc. confirmed receipt of a Health Canada Medical Device Licence authorizing the Canadian commercialization of its CARA System effective July 23, 2026. This clearance allows the company to advance its service delivery to IRIS The Visual Group, as announced on June 7, 2022, and to implement its marketing strategy focused on Canadian optometry providers.

The company notes CARA is believed to be one of the first Canadian AI retinal image analysis platforms developed specifically for optometrists to earn a Class II medical device licence from Health Canada. This classification confirms the device meets stringent safety and efficacy standards mandated by Canadian regulators. The licence represents the culmination of over a decade of AI retinal imaging research and development.

Advanced Technology and Clinical Features of CARA System

The CARA System integrates multiple AI modules within a single clinician-controlled workflow, including CARA-AMDdetect for age-related macular degeneration detection, CARA-DR for diabetic retinopathy detection, CARA-MVA for retinal microvascular analysis, CARA-Enhancement for enhanced retinal imaging, and CARA-CWS, a workspace for clinician annotations and notes.

This technology combines image enhancement, explainable AI outputs, fundus indicators, and retinal vascular analytics to deliver objective insights from fundus photos. The platform is designed to keep optometrists fully in control of clinical decisions, with AI serving to reveal clinical information that may be difficult to detect visually. This clinician-centric approach ensures AI augments rather than replaces professional judgment.

Canadian Optometry Market Opportunity

Retinal photography is a standard part of optometry workflows in independent practices and major eye care networks across Canada and globally. The widespread use of fundus imaging creates a substantial clinical data base that can benefit from AI-assisted analysis. DIAGNOS positions CARA as a tool to extract deeper clinical insights from images routinely captured during eye exams.

The company has not disclosed specific figures on the number of target optometry practices, revenue forecasts following Health Canada approval, or timelines for IRIS The Visual Group integration and deployment. Investors may look for future updates on CARA adoption rates within Canadian optometry networks.

Regulatory Strategy and Global Expansion Plans

Beyond Health Canada approval, DIAGNOS is seeking regulatory clearances in key international markets. The CARA System has been submitted for marketing authorization with Saudi Arabia’s Food & Drug Authority (SFDA), with the company currently responding to regulator queries as of the June 11, 2026 MD&A report.

In the U.S., a legacy CARA version remains cleared for commercialization as a Medical Image Management and Processing System. DIAGNOS plans to submit an application for the updated CARA System to the U.S. Food and Drug Administration by the end of September 2026, supported by a U.S.-based regulatory consultant. The company has not specified whether the FDA submission will follow a 510(k) or alternative regulatory pathway.

Executive Insights on Milestone and Innovation

André Larente, President and CEO of DIAGNOS, stated: "For over a decade, DIAGNOS has collaborated with clinicians and healthcare organizations worldwide to develop AI for retinal image analysis, driven by our mission to help prevent avoidable blindness." This highlights the company’s long-term commitment to clinically validated AI tools in ophthalmology.

Philippe Couillard, Board Chairman, described the Health Canada licence as a success not only for DIAGNOS but also for Quebec’s innovation ecosystem, emphasizing the scientific excellence, clinical rigor, and perseverance required to develop AI for regulated medical devices. Yves-Stephane Couture, COO, expressed enthusiasm about introducing CARA to Canadian optometrists, noting the platform "transforms routinely acquired retinal images into deeper clinical insights while ensuring clinicians remain central to every decision."

Medical Device Regulatory Compliance Emphasis

DIAGNOS underscores that the CARA System is a medical device requiring local regulatory authorization for commercialization in most markets. Regulatory compliance is presented as essential for public safety and patient protection. The company acknowledges that regulatory approval is mandatory for lawful commercialization in regulated healthcare sectors.

The announcement does not detail the specific Canadian classification pathway, timelines for Saudi Arabia or U.S. regulatory reviews, or submission costs. Investors seeking detailed regulatory timelines or expenses should consult DIAGNOS’s financial disclosures and reports on SEDAR+.

Company Overview and Mission

DIAGNOS Inc. is a publicly traded Canadian firm focused on early detection of critical eye health issues using AI technologies. The company trades on the TSX Venture Exchange (ADK), OTCQB (DGNOF), and Frankfurt Stock Exchange (4D4A). Its mission is to enhance diagnostic accuracy, streamline clinical workflows, and improve patient outcomes globally through AI-driven analysis tools.

The company’s focus on AI-assisted retinal imaging aligns with healthcare trends toward computer-aided diagnostics that support clinical decision-making in ophthalmology. The announcement does not provide financial metrics such as revenue, profitability, or R&D expenditures.

Forward-Looking Statements and Regulatory Disclaimers

The release includes forward-looking statements cautioning that actual results may differ materially from expectations, and DIAGNOS disclaims any obligation to update such statements publicly. The TSX Venture Exchange’s regulatory services provider does not accept responsibility for the release’s accuracy.

No specific financial forecasts, revenue guidance, or profitability timelines are disclosed. Statements regarding the planned FDA submission by September 2026 are qualified by these disclaimers. Investors should review full company filings on SEDAR+ for comprehensive risk and financial information.

Investor Considerations and Resources

The immediate impact on share price was not evident at the time of the announcement. Investors interested in DIAGNOS’s business, financial health, competitive landscape, and regulatory strategy should examine the company’s full disclosures, including the MD&A available on SEDAR+ and at www.diagnos.com.

The Health Canada licence represents a key regulatory achievement in Canada, but commercial success depends on adoption rates among optometrists, clinical acceptance of the AI platform, competitive market dynamics, and securing further approvals in the U.S. and Saudi Arabia. Future updates on deployment, partnerships, and international regulatory progress will be important to monitor.