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DIAGNOS is filing for the Saudi FDA Authorization of Its CARA SYSTEM, an AI Assisted Medical Device

by GlobeNewswire
March 12, 2025
in Top News
Reading Time: 3 mins read

BROSSARD, Quebec, March 12, 2025 (GLOBE NEWSWIRE) — Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health issues through the use of its FLAIRE platform based on Artificial Intelligence (AI), is pleased to announce that it is officially filing for Saudi Food and Drug Administration (Saudi FDA) authorization of its CARA SYSTEM, a machine-learning-enabled medical device (MLMD). To ensure a smooth regulatory process, DIAGNOS is working with Kanhoor Medical company, our authorized representative for the Saudi Arabia market.

The CARA SYSTEM is designed to assist frontline healthcare professionals in processing, analyzing and annotating fundus images for the early detection of diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy. 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.

With this new filing, we will upgrade our present Medical Device Marketing Device Authorization to include the early detection of diabetic retinopathy, age-related macular degeneration and at a later date, hypertensive retinopathy.

“DIAGNOS is committed to revolutionizing eye health through Artificial Intelligence technologies,” said André Larente, CEO of DIAGNOS. “Our expertise in Artificial Intelligence driven diagnostics is helping to improve patient outcomes worldwide. As per the latest IDF (International Diabetic Federation), the prevalence of diabetes in adults was at 17,7% in Saudi Arabia, or more than 4 million patients at risk of some level of vision loss. Our solution can help triage this population efficiently to prevent permanent damage on vision caused by the complication of diabetes. Our local partner, Kanhoor Medical is helping with government-related business initiatives, marking an exciting phase of growth for DIAGNOS.”

About Kanhoor Medical
Kanhoor Medical is a Saudi company based in Riyadh, specializing in providing technology solutions for the healthcare sector. It focuses on developing medical software to enhance operational efficiency in healthcare institutions. The company aims to deliver innovative solutions that comply with regulatory requirements, such as those set by the Saudi Food and Drug Authority (SFDA), ensuring high standards of quality and compliance in the healthcare industry.

About DIAGNOS
DIAGNOS is a publicly traded Canadian corporation dedicated to early detection of critical health problems based on its FLAIRE Artificial Intelligence (AI) platform. FLAIRE allows for quick modifying and developing of applications such as CARA (Computer Assisted Retina Analysis). CARA’s image enhancement algorithms provide sharper, clearer and easier-to-analyze retinal images. CARA is a cost-effective tool for real-time screening of large volumes of patients.

Additional information is available at www.diagnos.com  and www.sedarplus.com.  

This news release contains forward-looking information. There can be no assurance that forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in these statements. 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 news release is expressly qualified by this cautionary statement.

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.

CONTACT: For further information, please contact:

Mr. André Larente, President
DIAGNOS Inc.
Tel: 450-678-8882 ext. 224
alarente@diagnos.ca

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GlobeNewswire
GlobeNewswire
GlobeNewswire,is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.
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