NANO-X Imaging Ltd. has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for the Nanox.ARC, a stationary X-ray system designed to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography.

The Nanox.ARC features a proprietary digital X-ray source, representing a significant advancement in X-ray technology, according to the company. The Nanox.ARC 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.

“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,” Nanox CEO/Acting Chairman Erez Meltzer said. “Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC—a solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care. We look forward to bringing this technology to more healthcare facilities throughout the country.”

The company claims the new FDA-cleared indications will help broaden Nanox.ARC’s commercial expansion in the United States, where it is currently deployed at multiple healthcare facilities in seven states. Worldwide, there are a few dozen units in various stages of shipments and deployments for both commercial and clinical uses.

“The installation of the Nanox.ARC at our facility marks a significant leap forward in our diagnostic capabilities,” said Sherri Donaldson, chief operating officer at Diagnostic Radiology Institute of Kansas City, located in Mission, Kan. “This technology allows us to provide our patients with advanced imaging services, potentially reducing wait times and improving the overall patient experience. We’re excited to be at the forefront of this technological advancement in medical imaging.”

The 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 operated by trained radiographers, radiologists, and physicians. It is designed to allow easy and efficient integration into current clinical workflows. The Nanox.ARC can potentially reduce patient wait times, enabling faster care and more efficient diagnosis, while also possibly reducing the need to visit a separate imaging facility.

“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,” said Greg Kicska M.D., Ph.D, assistant professor at Harborview Medical Center and Nanox Advisory Board member. “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 utilizes a matrix pattern that blurs out structural noise, making images more clean.”

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 novel digital source. The Nanox ecosystem includes Nanox.ARC, a multi-source digital tomosynthesis system; Nanox.AI, an artificial intelligence-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 comprehensive teleradiology services platform. By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide.