Nanox Imaging (NASDAQ:NNOX) has announced that its Nanox.ARC stationary X-ray system has received 510(k) clearance from the FDA, allowing general use including the human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, and is an adjunctive to conventional radiography, on adult patients.
The company highlighted that its proprietary digital X-ray Nanox.ARC employs advanced tomosynthesis technology and a cold cathode to create more comprehensive, layered three-dimensional views of the body. This approach enhances visualization with multiple layers of images and reduces the super-imposition of structures typically seen in 2D X-rays.
“With this FDA clearance, we can now offer U.S. healthcare providers significantly broader imaging capabilities that are akin to commonly used traditional X-ray devices,” said Erez Meltzer, CEO and acting chairman of Nanox.
“Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC—an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care. We look forward to bringing this technology to more healthcare facilities throughout the country,” he added.
