Diagnos Inc. (“DIAGNOS” or the “Corporation”), 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 Saudi Food and Drug Administration (Saudi FDA) authorization of its CARA SYSTEM, a machine-learning-enabled medical device (MLMD). To ensure a smooth regulatory process, DIAGNOS is working with Kanhoor Medical company, our authorized representative for the Saudi Arabia market.
The CARA SYSTEM is designed to assist frontline healthcare professionals in processing, analyzing and annotating fundus images for the early detection of diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy. By leveraging Artificial Intelligence, DIAGNOS aims to provide more information to healthcare clinicians to enhance diagnostic accuracy, streamline workflows, and improve patient outcomes on a global scale.
With this new filing, we will upgrade our present Medical Device Marketing Device Authorization to include the early detection of diabetic retinopathy, age-related macular degeneration and at a later date, hypertensive retinopathy.
“DIAGNOS is committed to revolutionizing eye health through Artificial Intelligence technologies,” said André Larente, CEO of DIAGNOS. “Our expertise in Artificial Intelligence driven diagnostics is helping to improve patient outcomes worldwide. As per the latest IDF (International Diabetic Federation), the prevalence of diabetes in adults was at 17,7% in Saudi Arabia, or more than 4 million patients at risk of some level of vision loss. Our solution can help triage this population efficiently to prevent permanent damage on vision caused by the complication of diabetes. Our local partner, Kanhoor Medical is helping with government-related business initiatives, marking an exciting phase of growth for DIAGNOS.”