DIAGNOS Submits Request for Information to US FDA for CARA System

01:24 PM EDT, 09/28/2026 (MT Newswires) -- DIAGNOS (ADK.V) submitted a Section 513(g) Request for Information to the US Food and Drug Administration (FDA) in relation to the classification and applicable regulatory requirements for its CARA System, it said Monday. "CARA System is the logical progression of DIAGNOS' existing Medical Image Management and Processing System (MIMPS)," said the company in a release. The submission, which follows the company's FDA Pre-Submission filing, was filed to address a specific recommendation received from the FDA, added the company. "This submission represents another milestone in our strategy to bring CARA System to the U.S. market," said DIAGNOS President Andre Larente. "Building on its established license in Canada, for the optometry market, DIAGNOS is pursuing a separate regulatory pathway in the U.S. to access a market of approximately 49,500 optometrists, seeing strong commercial potential in both markets for its AI-assisted solution designed to streamline clinical workflows, ensure diagnostic consistency, and support early detection in everyday optometric practice," the statement added. The company's shares were last seen down CA$0.01, or 2%, at CA$0.48 on the TSX Venture Exchange. Price: 0.48, Change: -0.01, Percent Change: -2.04