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]

Core Insights - Diagnos Inc. has appointed Dr. Philippe Couillard as Chairman of the Board, which is seen as a strategic move to enhance the company's governance and growth during a pivotal time for its AI-enabled product CARA [1][3] Company Overview - Diagnos Inc. is a publicly traded Canadian corporation focused on the early detection of critical eye-related health issues using advanced AI technology [4] - The company aims to improve diagnostic accuracy, streamline workflows, and enhance patient outcomes globally [4] Leadership Background - Dr. Philippe Couillard is a seasoned business advisor and neurosurgeon with significant public service experience, having served as Minister of Health and Social Services and Premier of Quebec [2] - He joined the Board of Diagnos on April 1, 2024, and his expertise is expected to contribute to the company's success in major markets [2][4] Market Expansion - The company is actively pursuing regulatory licenses and approvals for its flagship product CARA in Canada, the United States, and Saudi Arabia [3] - The progress in these applications is described as advancing at a fast pace, indicating a strong potential for market entry [3]

Core Insights - DIAGNOS Inc. has successfully completed its annual surveillance external quality compliance audit under the Medical Device Single Audit Program (MDSAP), confirming full compliance with no non-conformities [1][2] - The audit results led to the reissuance of the company's certification, reflecting its Software-as-a-Service (SaaS) deployment model for its AI-assisted medical image-analysis platform, aligning with its global strategy [3] Compliance and Quality Assurance - The audit confirmed that DIAGNOS adheres to rigorous quality and regulatory standards, demonstrating a strong commitment to continuous improvement [2] - The MDSAP program aims to streamline regulatory audits for medical device manufacturers, allowing a single annual audit to meet the requirements of multiple countries [4] Company Strategy and Future Outlook - The renewed certification signals DIAGNOS' readiness to scale its SaaS-based AI platform globally while maintaining compliance with regulatory standards [3] - The company emphasizes its mission to support healthcare professionals in the early detection of critical health issues using AI technology [3][6]

BROSSARD, Quebec, Sept. 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 Artificial Intelligence (AI) technologies, announces the voting results of the annual meeting of the shareholders held earlier today. Mr. André Larente, Mr. Robert Dunn, Mr. Michael Braeuel and Mr. Philippe Couillard were elected as directors to hold office until the closing of the next annual meeting of t ...