00:18:38 EDT Thu 09 Apr 2026
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Diagnos Inc (3)
Symbol ADK
Shares Issued 120,412,549
Close 2026-04-08 C$ 0.255
Market Cap C$ 30,705,200
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Diagnos talks regulatory progress for Cara

2026-04-08 20:43 ET - News Release

Mr. Andre Larente reports

DIAGNOS PROVIDES AN UPDATE ON SALES AND REGULATORY ACTIVITIES FOR CARA

Diagnos Inc. has provided an update to the news release dated Jan. 13, 2026, on the regulatory pathway for the future version of its flagship product, Cara, which incorporates eye-related disease detection algorithms, and the April 1, 2026, news release 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: The company is targeting submission to Health Canada (HC) in May, 2026. HC's review timelines remain subject to HC's processes.
  • United States:
    • As mentioned in the news 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 the company's U.S.-based regulatory consultant, Diagnos's 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 the company's current fiscal year.

"Our priority is to advance Cara through the relevant regulatory processes with rigour and discipline while simultaneously preparing for commercialization in our target markets," stated Andre Larente, chief executive officer of Diagnos.

About Diagnos Inc.

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 health care clinicians to enhance diagnostic accuracy, streamline workflows and improve patient outcomes on a global scale.

We seek Safe Harbor.

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