Core Viewpoint - Nanox Imaging Ltd is advancing its innovative medical imaging technology, particularly the Nanox.ARC system, which has received CE mark certification and FDA clearance, marking significant milestones for its commercialization in Europe and the U.S. [3][4] Group 1: Product and Technology - The Nanox.ARC is a stationary X-ray system that utilizes a proprietary digital X-ray source and advanced tomosynthesis technology, providing a comprehensive three-dimensional view of the body [2] - The system is designed to generate tomographic images from a single sweep, enhancing diagnostic capabilities while reducing patient radiation exposure and radiologist reading time [5][10] Group 2: Clinical Performance and Studies - New data will be presented at the 2025 European Congress of Radiology, highlighting the diagnostic potential of the Nanox.ARC in musculoskeletal imaging and its effectiveness in detecting lung nodules under simulated obesity conditions [5][10] - A clinical study demonstrated that digital tomosynthesis improved the detection of occult fractures and lesions, providing diagnostic value in 17 out of 19 cases compared to standard X-ray and CT [6][10] Group 3: Regulatory Milestones - The receipt of the CE mark and FDA 510(k) clearance signifies a major step in the global commercialization strategy for the Nanox.ARC system, allowing it to be marketed in Europe and the U.S. [3][4] Group 4: Company Vision and Ecosystem - Nanox aims to drive the transition to preventive healthcare by offering a comprehensive suite of affordable medical imaging technologies, leveraging AI for enhanced diagnostics [8] - The Nanox ecosystem includes various components such as Nanox.AI, Nanox.CLOUD, and Nanox.MARKETPLACE, which collectively aim to improve early detection and treatment of diseases [8]
Nanox to Present New Clinical Data on Nanox.ARC Advanced 3D Digital Tomosynthesis Imaging System at ECR 2025