NANO-X IMAGING Ltd. has received CE (Conformité Européenne) mark certification to market the multi-source Nanox.ARC system, including the Nanox.CLOUD, its accompanying cloud-based infrastructure.  Nanox.ARC is a stationary X-ray system, intended to generate tomographic images of human anatomy from a single tomographic sweep performed in recumbent positions of adult patients.

The Nanox.ARC features a proprietary digital X-ray source, representing a significant advancement in X-ray technology, according to the company. The system utilizes advanced tomosynthesis technology with a cold cathode to create a more comprehensive, sliced three-dimensional view of the body, enhancing visualization with multiple layers of images and reducing the super-imposition of structures often seen in 2D X-rays.

“Receiving the CE mark represents a significant milestone in our global expansion effort, building on the Nanox.ARC’s recent FDA clearance for general use,” Nanox CEO/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 company believes the CE Mark may help broaden Nanox.ARC’s commercial expansion globally and specifically in Europe, where worldwide, there are a few dozen units in various stages of shipments and deployments for both commercial and clinical uses.

Nanox.ARC is intended for use in professional healthcare ‎facilities or ‎radiological ‎environments, such as ‎hospitals, clinics, imaging ‎centers and ‎other medical practices‎, and is intended to be operated by qualified personnel with the necessary knowledge and expertise to operate X-ray equipment, such as radiographers, ‎physicians, and physicists, in accordance with the relevant country-specific regulations. It is designed to allow easy and efficient integration into current clinical workflows.

Nanox.ARC’s advanced tomosynthesis system is designed to support better patient care. It bridges the gap between standard X-rays and CT scans, offering advanced clinical imaging, increasing clinicians’ diagnostic confidence by allowing new clinical insights not available in conventional X-ray with only a fraction of the radiation exposure of a CT scan.

Nanox is conducting clinical trials featuring the Nanox.ARC at multiple sites and has published data demonstrating its visualization capabilities allowing clinicians utilizing the Nanox.ARC system to detect occult lesions and fractures which were not detected on conventional radiography.

Nanox is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and proprietary digital X-ray source.

Nanox’s vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging artificial intelligence to enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment and maintaining a clinically driven approach. The Nanox ecosystem includes Nanox.ARC—a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI Ltd., a subsidiary of Nanox Imaging, an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD—a cloud-based software platform that manages and stores data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE—a proprietary decentralized marketplace through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts, and a teleradiology services platform. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide.