Israeli medical imaging technology company Nano-X Imaging (Nanox) has received the US Food and Drug Administration (FDA) 510(k) approval for its Nanox.ARC imaging system.
Nanox.ARC is a stationary X-ray system with a unique digital X-ray source and is indicated for producing tomographic images for general use.
It can be used for imaging the human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, in addition to conventional radiography, on adult patients.
Nanox.ARC leverages advanced tomosynthesis technology with a cold cathode to create a more comprehensive, sliced three-dimensional view of the body.
The system enhances the visualisation with multiple layers of images and reduces the super-imposition of structures often seen in 2D X-rays.
Nanox CEO and acting chairman Erez Meltzer said: “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.
“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.”
Nanox.ARC is intended for use in professional healthcare facilities, such as hospitals, clinics, and imaging centres, operated by trained radiographers, radiologists, and physicians.
The system is designed for easy and effective integration into current clinical workflows.
It provides potential benefits, including reduced patient wait times, faster care and effective diagnosis, while reducing the need to visit a separate imaging facility.
According to the company, the FDA approval will help widen the expansion of Nanox.ARC in the US, where the system is currently deployed in healthcare facilities across seven states.
Harborview Medical Centre assistant professor and Nanox advisory board member Greg Kicska said: “Digital tomosynthesis provides added value in certain clinical situations.
“Musculoskeletal, thoracic and abdominal imaging all have use cases that may be best served by digital tomosynthesis compared to CT or radiography.
“The Nanox system is also unique in that it doesn’t have as large a footprint as traditional X-ray machines, doesn’t require as much power and utilises a matrix pattern that blurs out structural noise, making images more clean.”
