NANO-X IMAGING LTD announced today that its Nanox.ARC imaging system has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for general use. This clearance includes indications for the human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus imaging, adjunctive to conventional radiography, on adult patients.
The Nanox.ARC system utilizes a proprietary digital X-ray source and advanced tomosynthesis technology with a cold cathode, providing a more comprehensive, sliced three-dimensional view of the body. This technology aims to enhance visualization by reducing the super-imposition of structures often seen in 2D X-rays.
This expanded FDA clearance is expected to broaden Nanox.ARC’s commercial expansion in the U.S., where the system is currently deployed at multiple healthcare facilities across seven states. The company believes this milestone will allow it to offer U.S. healthcare providers significantly broader imaging capabilities, akin to commonly used traditional X-ray devices.
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