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Nanox Receives MDR CE Mark for HealthOST, an Advanced AI-Powered Software for Spine Assessment
Globenewswire· 2025-06-05 12:00
Core Viewpoint - Nanox Imaging Ltd has received EU MDR CE mark certification for its HealthOST software, enabling commercialization in Europe and ensuring compliance with regulatory standards for medical software [1][2]. Company Overview - Nanox is an innovative medical imaging technology company focused on preventive healthcare through affordable imaging technologies based on advanced AI [10][11]. - The company aims to enhance early detection and treatment of diseases, improving health outcomes globally [11]. Product Details - HealthOST is an advanced software solution that analyzes routine CT scans to assess vertebral height loss and bone mineral density, aiding in the evaluation of musculoskeletal diseases like osteoporosis [2][8]. - The software integrates with existing picture archiving and communication systems (PACS) and requires no additional imaging or patient time, making it a cost-effective screening tool [3][5]. Market Need - Osteoporosis affects over 25.5 million women in Europe, with a significant portion of vertebral compression fractures going undetected [4]. - The annual cost of osteoporosis-related fractures in Europe exceeds €56 billion, with cases expected to increase by 25% by 2034 due to an aging population [4]. Clinical Impact - In the ADOPT study, HealthVCF identified over 3,450 new patients with vertebral compression fractures, highlighting the software's effectiveness in detecting previously undiagnosed cases [6][7]. - The integration of Nanox.AI's solutions has shown to improve patient outcomes and reduce the burden on healthcare systems through preventive care [7].