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DIAGNOS Advances Regulatory Strategy for CARA in Key Markets: Updates on Health Canada, FDA, and SFDA Progress
Globenewswire· 2026-01-13 14:00
Core Insights - Diagnos Inc. is advancing its AI platform CARA for early detection of eye-related health issues and is focused on securing regulatory approvals in Canada, the U.S., and Saudi Arabia [1][2][6] Regulatory Pathway - The company is actively working to meet the regulatory standards in three key jurisdictions: Canada, the U.S., and Saudi Arabia [2] - In Saudi Arabia, CARA has been formally submitted for marketing approval to the Saudi Food and Drug Authority (SFDA) [6] - In Canada, the company is engaged with Health Canada to align with medical device regulations and plans to submit a formal application for CARA in the current quarter [6] - In the U.S., after strategic meetings with the FDA, the company has clarified the requirements for obtaining 510(k) clearance, facilitating the path to commercialization [6] Company Overview - Diagnos Inc. is a publicly traded Canadian corporation focused on the early detection of critical eye-related health problems using Artificial Intelligence [3] - The company's goal is to enhance diagnostic accuracy, streamline workflows, and improve patient outcomes globally [3]
DIAGNOS Welcomes Veteran Optometrist Dr. Barry A. Ginsberg to its Scientific Advisory Board for the United States
Globenewswire· 2025-06-25 13:00
BROSSARD, Quebec, June 25, 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 using advanced technology based on Artificial Intelligence (AI), is thrilled to announce that Dr. Barry A. Ginsberg, O.D. has joined the Corporation’s Advisory Board. Mr. Weiner will team up with Dr. Tomas J. Philipson, former vice chairman and acting chairman of the White House Council of Economic Advisers and M ...