DIAGNOS to File for FDA Pre-Market Authorization of Its AI-Powered CARA SYSTEM and Engages Ora as Regulatory Specialist

BROSSARD, Quebec, Feb. 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 through the use of its FLAIRE platform based on Artificial Intelligence (AI), is pleased to announce that it is officially filing for U.S. Food and Drug Administration (FDA) pre-market authorization of its CARA SYSTEM, a machine-learning-enabled medical device (MLMD). To ensure a smooth regulatory process, DIAGNOS has engaged ORA, a leading clinical research organization specializing in regulatory affairs and clinical development for ophthalmic products.