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Nanox.ARC Imaging System Receives FDA Clearance, Pioneering a New Era in Medical Imaging
Nanox.ARC presents high powered digital X-ray tubes for 3D tomosynthesis imagingNanox.ARC could help expand the availability of medical imaging NEVE ILAN,
About this update from Nano-x Imaging Ltd
[{"type":"text","content":"Nanox.ARC presents high powered digital X-ray tubes for 3D tomosynthesis imagingNanox.ARC could help expand the availability of medical imaging NEVE ILAN, Israel, May 01, 2023 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (\"Nanox\" or the \"Company,\" Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the multi-source Nanox.ARC, including the Nanox.CLOUD, its accompanying cloud-based infrastructure. Nanox.ARC is a stationary X-ray system intended to produce tomographic images of the human musculoskeletal system adjunctive to conventional radiography on adult patients. Representing a major advancement in X-ray technology, Nanox.ARC is a multi-source digital 3D tomosynthesis system that utilizes novel, cold cathode X-ray tubes, which the Company intends to offer using an innovative pay-per-scan business model. The FDA cleared Nanox.ARC for use in professional healthcare facilities or radiological environments, such as hospitals, clinics, imaging centers, and other medical practices by trained radiographers, radiologists, and physicians, and has the potential to increase availability to medical imaging around the world, once approved by local regulatory authorities and deployed at scale. The Company received 510(k) clearance to market its single-source X-ray device, known as the Nanox Cart X-Ray System, in April 2021. The multi-source Nanox.ARC has the ability to reconstruct a series of 2D projection images into a stack of tomograms (or slices) of the imaged object, forming a 3D visualization. This visualization reduces the effect of overlying structures and provides in-depth information on structures of interest. “Today’s milestone is a significant achievement as part of our commitment to make state-of-the-art medical imaging technology available for use in a wide array of professional healthcare facilities and other medical practices,” said Erez Meltzer, Chief Executive Officer of Nanox. “Our vision is that Nanox's innovative technology and approach not only have the potential to increase access to medical imaging, but also to shift healthcare from reactive to proactive—enabling early detection and prevention of diseases.” Following this clearance, Nanox will continue to work with the FDA to pursue ad...