Medical imaging technology company Nanox Imaging has received a CE mark certification to market its multi-source Nanox.ARC system.
This system includes the Nanox.CLOUD, an accompanying cloud-based infrastructure designed to manage and store data collected by Nanox devices.
The Nanox.ARC is a stationary X-ray system that produces tomographic images of human anatomy in a single tomographic sweep. It is designed for adult patients in a recumbent position.
Nanox Imaging stated that the X-ray system can be used for general diagnostic purposes, including musculoskeletal, pulmonary, intra-abdominal, and paranasal sinus applications. It serves as an adjunct to conventional radiography for adult patients.
The Nanox.ARC features a proprietary digital X-ray source, advancing X-ray technology.
It incorporates advanced tomosynthesis technology with a cold cathode, offering a detailed, sliced 3D view of the body. This reduces structural overlap, which is often seen in 2D X-rays, improving image clarity and visualisation.
Nanox Imaging claims that the Nanox.ARC’s advanced tomosynthesis enhances patient care by bridging the gap between standard X-rays and CT scans.
According to the company, the technology provides advanced clinical imaging, offering clinicians new diagnostic insights with a fraction of the radiation exposure compared to CT scans.
The latest marketing clearance follows 510(k) clearance from the US Food and Drug Administration (FDA) in December 2024.
Nanox Imaging anticipates that the CE mark will support the Nanox.ARC’s global expansion, particularly in Europe.
Currently, several dozen units are being shipped and deployed for both commercial and clinical use worldwide.
Nanox CEO and acting chairman Erez Meltzer said: “This certification for whole-body imaging in Europe, combined with our existing distributors and ongoing pursuit of strategic partnerships, positions us to accelerate the Nanox.ARC’s commercial introduction across the region.”
The Nanox ecosystem includes Nanox.ARC, Nanox.AI, an artificial intelligence (AI)-based suite of algorithms, Nanox.CLOUD, and Nanox.MARKETPLACE.
Nanox Imaging designed the Nanox.ARC for use in healthcare facilities such as hospitals, clinics, imaging centres, and other medical practices.
It is intended to be operated by qualified professionals, including radiographers, physicians, and physicists, following country-specific regulations. The system integrates easily into existing clinical workflows, according to the company.
Nanox Imaging is conducting clinical trials with the Nanox.ARC at multiple sites. The company stated that published data indicates the system enhances visualisation, enabling clinicians to detect occult lesions and fractures that may be missed by conventional radiography.
