Nanox.ARC Imaging System Receives FDA Clearance for General Use
The U.S. Food and Drug Administration (FDA) has cleared Nanox.ARC, a stationary X-ray system, for general use, including pulmonary indications. The system utilizes a digital X-ray source.
Nano-X Imaging LTD. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nanox.ARC stationary X-ray system. This clearance allows for the production of tomographic images for general use, encompassing pulmonary, intra-abdominal, and paranasal sinus indications, in addition to the system's previously cleared use for the musculoskeletal system.
The Nanox.ARC system features a proprietary digital X-ray source and employs tomosynthesis technology. Utilizing a cold cathode, it generates 3D images by creating multiple layers of views, which enhances visualization and reduces the superimposition of structures common in 2D X-rays. The company anticipates this expanded clearance will facilitate the broader commercial deployment of Nanox.ARC within the U.S., where it is currently operational at healthcare facilities in seven states.
"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," stated Erez Meltzer, Nanox CEO. The company aims to provide healthcare practices with an accessible and cost-effective solution designed to advance diagnostic imaging and improve patient care.
The Nanox.ARC is intended for use in professional healthcare settings and radiological environments. It is designed to potentially reduce patient wait times and expedite diagnoses. While already deployed in several U.S. facilities, the expanded FDA clearance is expected to drive further commercial adoption.