Nano-X has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Nanox.ARC X-ray system.
The FDA has cleared the system for use in healthcare facilities and radiological departments of hospitals, imaging centres, and clinics.
The system, which has an accompanying cloud component, is a stationary system that can produce tomographic images of the musculoskeletal system adjunctive to traditional radiography use. The Nanox.ARC is a multi-source digital 3D tomosynthesis system and the company says it will use a pay-per-scan business model.
According to the Israel-based company, the Nanox.ARC’s ability to produce a 3D visualization from a series of stacked 2D slices means radiologists can gain better information from points of interest by reducing the effect of overlaying structures.
GlobalData forecasts that the X-Ray system market will be worth $4.1bn by 2030. Amidst a competitive market, NanoX’s intention to use a pay-per-scan business model aims to expand diagnostic imaging to more healthcare settings.
“The FDA clearance of Nanox.ARC represents an important breakthrough and represents an opportunity to increase the availability and accessibility of medical imaging in the United States and worldwide,” said Geoffrey Rubin, MD, MBA, Professor and Chairman of the Department of Medical Imaging at the University of Arizona and a member of Nanox’s Advisory Board.
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“Medical imaging is essential for detecting, diagnosing, and managing disease, guiding treatment decisions for improved health outcomes. Nanox.ARC has the potential to be a cost-effective and scalable imaging solution in healthcare settings that would otherwise be unable to deploy traditional medical imaging equipment.”