April 2, 2021 — Nano-X Imaging Ltd. (Nanox), an innovative medical imaging technology company, announced that its single-source Nanox.ARC digital X-ray technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
“Obtaining 510(k) clearance from the FDA for our single-source Nanox.ARC digital X-ray is a significant step forward along our U.S. regulatory pathway,” stated Ran Poliakine, chairman and chief executive officer of Nanox. “We remain on track to commence system shipments in the fourth quarter of 2021 and the first quarter of 2022 with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024.”
“We believe we are well positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world’s population who currently have limited or no meaningful access to imaging or the preventative screening that it offers,” Poliakine concluded.
The company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the company’s commercial imaging system that it expects to deploy broadly across the globe.
The system is unique in that it uses cold-cathod X-ray technology. This greatly reduces the amount of heat generated and the amount of energy consumed, allowing for much lighter weight and less expensive X-ray systems.
Read more about this technology in the article Cold Cathode X-ray Technology Demonstrated at RSNA 2020.
For more information: www.nanox.vision