Nano-X Imaging’s Nanox.ARC imaging system receives FDA clearance

Nano-X Imaging (NNOX) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its Nanox.ARC, a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients. “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, Nanox CEO and Acting Chairman. “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.” The company believes the new FDA-cleared indications will help broaden Nanox. ARC’s commercial expansion in the U.S., where it is currently deployed at multiple healthcare facilities across seven states.