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Diagnos Inc. ("Diagnos" or the "Corporation") (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a company dedicated to the early detection of eye-related health using Artificial Intelligence (AI) techniques, is pleased to provide an update to the press release dated January 13, 2026 on the regulatory pathway for the future version of its flagship product CARA, which incorporates eye-related disease detection algorithms, and April 1, 2026 announcement regarding U.S. establishment registration renewal and the continued U.S. commercialization status of the legacy version of CARA.
- Saudi Arabia: Diagnos remains engaged in the Saudi Food and Drug Authority review process and will provide further material updates as appropriate.
- Canada: We are targeting submission to Health Canada (HC) in May 2026. HC's review timelines remain subject to HC's processes.
- United States (U.S.):
- As mentioned in the press release dated April 1, 2026, (i) the legacy version of CARA, as a Medical Image Management and Processing System, remains cleared for commercialization in the U.S and (ii) the annual registration for the Corporation's medical device establishment with the U.S. Food and Drug Administration (FDA) had been successfully completed. Medical device manufacturers, such as Diagnos, are required by the FDA to register their facilities to commercialize their products and services in the U.S.
- With the help of our U.S. based regulatory consultant, our goal is to be able to submit the commercialization application of the future version of CARA to the FDA before the end of the third quarter of our current fiscal year.
- As mentioned in the press release dated April 1, 2026, (i) the legacy version of CARA, as a Medical Image Management and Processing System, remains cleared for commercialization in the U.S and (ii) the annual registration for the Corporation's medical device establishment with the U.S. Food and Drug Administration (FDA) had been successfully completed. Medical device manufacturers, such as Diagnos, are required by the FDA to register their facilities to commercialize their products and services in the U.S.
"Our priority is to advance CARA through the relevant regulatory processes with rigor and discipline while simultaneously preparing for commercialization in our target markets." stated André Larente, CEO of Diagnos.
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 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.
For further information, please contact: Mr. André Larente, President Diagnos Inc. Tel: 450-678-8882 ext. 224 alarente@Diagnos.ca
