DIAGNOS Files FDA Pre-Submission for its CARA System: Strategic Entry into the U.S. Optometry Market with Support from ORA LLC
MWN-AI** Summary
**DIAGNOS Files FDA Pre-Submission to Enter U.S. Optometry Market with CARA System**
BROSSARD, Quebec, July 16, 2025 (GLOBE NEWSWIRE) – Diagnos Inc. (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a Canadian innovative leader in artificial intelligence (AI) for early detection of retinal and systemic diseases, has submitted a Pre-Submission (Q-sub) to the U.S. Food and Drug Administration (FDA) for its CARA System. This move signifies DIAGNOS's strategic entry into the U.S. optometry market, supported by ORA LLC.
The CARA System is a cloud-based AI platform that offers optometrists rapid analysis of retinal images to identify signs of Diabetic Retinopathy (DR), Hypertensive Retinopathy (HR), Age-Related Macular Degeneration (ARMD), and other vascular or macular anomalies. The U.S. market boasts approximately 49,300 active optometrists, who conduct around 88 million eye exams each year. DIAGNOS aims to capitalize on this significant demand by providing an AI-enhanced solution that improves efficiency and consistency in optometric practices.
Designed to facilitate image analysis and present actionable results quickly, the CARA System allows optometrists to prioritize patient interactions while ensuring accurate disease detection. Yves-Stéphane Couture, COO of DIAGNOS, emphasized CARA's ability to streamline documentation and enhance early detection of critical conditions.
The system's foundation is robust, derived from retinal screenings covering over 450,000 patients across 16 countries, ensuring its adaptability and reliability in diverse healthcare environments. This breakthrough positions DIAGNOS to play a critical role in transforming optometric practices in the U.S. market, highlighting the essential link between ocular and systemic health.
For further inquiries, contact Mr. André Larente, President of DIAGNOS Inc. Provided forward-looking information reflects potential business capabilities which may not materialize as expected.
MWN-AI** Analysis
DIAGNOS Inc. is strategically positioning itself for entry into the lucrative U.S. optometry market through its recent Pre-Submission (Q-sub) to the FDA for the CARA System. This cloud-based AI solution offers significant potential, primarily by enhancing the efficiency of optometrists in diagnosing critical retinal and systemic diseases. Given the high volume of eye examinations performed annually—estimated at 88 million—there is a substantial demand for innovative solutions that improve diagnostic accuracy while streamlining workflows.
Investors should recognize the growth potential of DIAGNOS as it leverages advanced AI technology to tap into an unmet need in the market. The CARA System’s capabilities in evaluating retinal microcirculation not only bolster its appeal but also align with the increasing trend among healthcare providers to adopt AI-driven solutions for early disease detection. The fact that CARA has been validated by over 450,000 retinal images from diverse populations further enhances its credibility and broad applicability.
Moreover, partnering with ORA LLC underscores DIAGNOS' commitment to successfully navigating regulatory landscapes, which is crucial for gaining market entry. This alliance signals to investors that the company is taking rigorous steps to ensure compliance and has the expertise necessary to succeed in a competitive environment.
From a market outlook perspective, if DIAGNOS receives regulatory approval, the stock could experience upward momentum. The potential for expanding its footprint in the U.S. market, combined with increasing acceptance of AI in healthcare, suggests a favorable trajectory. Investors should consider monitoring DIAGNOS closely, particularly for updates regarding FDA feedback and subsequent commercialization steps, as these will significantly impact stock performance in the near future. Overall, DIAGNOS appears well-positioned to capitalize on emerging opportunities within the optometry landscape.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
BROSSARD, Quebec, July 16, 2025 (GLOBE NEWSWIRE) -- Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a Canadian leader in artificial intelligence ( AI ) for the early detection of retinal and systemic diseases, is proud to announce that it has formally submitted a Pre-Submission (Q-sub) to the U.S. Food and Drug Administration (FDA) for its flagship CARA System. This filing marks the first strategic step toward regulatory clearance and commercial deployment in the U.S. optometry market.
The CARA System—DIAGNOS’ cloud-based platform—is designed to inform optometrists by providing AI-assisted analysis of retinal images to detect indicators of Diabetic Retinopathy (DR), Hypertensive Retinopathy (HR), Age-Related Macular Degeneration (ARMD), and other vascular or macular anomalies.
The United States hosts approximately 49,300 actively practicing optometrists, according to the U.S. Bureau of Labor Statistics (May 2023) who, to the American Optometric Association, perform an estimated 88 million comprehensive eye exams annually. Given this high volume of routine evaluations, DIAGNOS sees a strong market for its AI assisted solution which is designed to enhance efficiency, ensure greater consistency, and support early detection in everyday optometric practice.
Enhancing Optometry Through AI-Driven Microcirculation Analysis
The CARA System also enables evaluation of the retina’s microcirculation—an important window into systemic vascular health—by analyzing subtle vascular changes that may indicate early disease.
“CARA has been designed to perform image analysis and provide informative results at the fingertips of optometrists, giving them more time to focus on meaningful patient interactions and recenter the patient at the heart of the visit,” said Yves-Stéphane Couture, Chief Operating Officer of DIAGNOS.
By delivering fast, AI-driven insights through a streamlined, intuitive interface, CARA not only accelerates documentation—it also enhances the role of the optometrist by providing tools to detect early signs of Age-Related Macular Degeneration (ARMD), Diabetic Retinopathy (DR), and Hypertensive Retinopathy (HR), supporting more accurate referrals and timely intervention for systemic conditions.
The eye is a window into your heart—and DIAGNOS gives optometrists the clarity to see through it. We are proud to take this significant step toward entering the U.S. market. We would like to express our sincere appreciation to ORA for their outstanding regulatory support and ophthalmic device expertise, which have been instrumental throughout the pre-submission process.”
CARA’s dataset is the result of screenings conducted in 16 countries, encompassing retinal images from over 450,000 patients. This global foundation ensures the robustness and adaptability of the system across diverse populations, enabling more reliable detection and information for clinical decision-making in various healthcare settings.
About DIAGNOS
DIAGNOS is a publicly traded Canadian corporation dedicated to early detection of 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 is available at www.diagnos.com and www.sedarplus.com .
This press release contains forward-looking information. We cannot guarantee that the forward-looking information mentioned will prove to be accurate, as there may be a significant discrepancy between actual results or future events and those mentioned in this statement. 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 press release is expressly covered by this caution.
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, PresidentDIAGNOS Inc.Tel: 450-678-8882 ext. 224alarente@diagnos.ca
FAQ**
How does Diagnos Inc. ADK:CC plan to address potential regulatory challenges during the FDA Pre-Submission process for the CARA System?
What competitive advantages does Diagnos Inc. ADK:CC believe the CARA System offers over existing solutions in the U.S. optometry market?
Can Diagnos Inc. ADK:CC provide insights into the expected timeline for receiving FDA clearance and subsequent commercial deployment of the CARA System?
How does Diagnos Inc. ADK:CC intend to leverage the data from screenings across 16 countries to enhance the effectiveness of the CARA System in diverse patient populations?
**MWN-AI FAQ is based on asking OpenAI questions about Diagnos Inc. (TSXVC: ADK:CC).
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