Israeli medical technology company Nano-X Imaging (Nanox) has received the US Food and Drug Administration (FDA) 510(k) approval for its multi-source imaging system, Nanox.ARC.
The FDA approval allows the marketing of Nanox.ARC imaging system, together with its associated cloud-based infrastructure, Nanox.CLOUD, in the US.
Nanox.ARC is a stationary X-ray system that provides tomographic images of the human musculoskeletal system, along with conventional radiography on adult patients.
It is a multi-source digital 3D tomosynthesis system that leverages novel, cold cathode X-ray tubes, which the company touts to be a major advancement in X-ray technology.
Nanox.ARC can reconstruct a series of 2D projection images into a stack of tomograms of the imaged object, to enable a 3D visualisation.
The visualisation reduces the effect of overlying structures and provides in-depth information on structures of interest, said the medical technology company.
Nanox chief executive officer Erez Meltzer said: “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.
“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.”
With the FDA approval, Nanox.ARC can be used in professional healthcare facilities, and radiological environments, such as hospitals, clinics, imaging centres, and other practices.
The medical imaging technology company intends to offer an advanced imaging system through a unique pay-per-scan business model.
Nanox.ARC imaging system has the potential to increase the availability of medical imaging worldwide, after being approved by local regulatory authorities, said the company.
Nanox advisory board member Geoffrey Rubin said: “The FDA clearance of Nanox.ARC represents an important breakthrough and represents an opportunity to increase the availability and accessibility of medical imaging in the United States and worldwide.
“Medical imaging is essential for detecting, diagnosing, and managing disease, guiding treatment decisions for improved health outcomes.
“Nanox.ARC has the potential to be a cost-effective and scalable imaging solution in healthcare settings that would otherwise be unable to deploy traditional medical imaging equipment.”
In April 2021, the medical imaging technology company received the FDA 510(k) approval to market its single-source X-ray device, dubbed Nanox Cart X-Ray System.
