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Nanox.ARC Imaging System Receives FDA Clearance for General Use, Including Pulmonary Indication
ARCARC Document Solutions(ARC) GlobeNewswire News Room·2024-12-05 10:55

Core Viewpoint - Nanox Imaging Ltd has received FDA clearance for its Nanox.ARC system, expanding its imaging capabilities to include pulmonary, intra-abdominal, and paranasal indications, in addition to its previous clearance for musculoskeletal imaging [2][4]. Group 1: FDA Clearance and Technology - The Nanox.ARC is a stationary X-ray system designed for general use, now cleared for multiple imaging indications [2]. - It features a proprietary digital X-ray source and advanced tomosynthesis technology, providing a three-dimensional view of the body and reducing the limitations of traditional 2D X-rays [3][4]. - The system is currently deployed in healthcare facilities across seven states in the U.S., with additional units being shipped worldwide [4]. Group 2: Impact on Healthcare Providers - The FDA clearance allows U.S. healthcare providers to access broader imaging capabilities similar to traditional X-ray devices, enhancing patient care [4]. - The technology aims to reduce patient wait times and improve overall diagnostic efficiency, potentially allowing for faster care without the need for separate imaging facilities [5][6]. - The system is designed for integration into existing clinical workflows, operated by trained professionals in various healthcare settings [5]. Group 3: Company Vision and Future Plans - Nanox aims to drive the transition to preventive healthcare through affordable medical imaging technologies, leveraging AI for smarter diagnostics [7][8]. - The company envisions expanding its technology beyond hospital settings, providing a comprehensive solution from scan to diagnosis [8]. - The Nanox ecosystem includes various components such as Nanox.AI for enhanced imaging analysis and Nanox.CLOUD for data management [9].