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Nanox Announces FDA Clearance of 510(k) for Single Source Nanox.ARC Digital X-Ray
NEVE ILAN, Israel--(BUSINESS WIRE)-- NANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company,
About this update from Nano-x Imaging Ltd
[{"type":"text","content":" NEVE ILAN, Israel--(BUSINESS WIRE)--\nNANO-X IMAGING LTD (NASDAQ: NNOX) (“Nanox” or the “Company”), an innovative medical imaging technology company, announced today that its single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the US Food and Drug Administration (the “FDA”).\n\n“Obtaining 510(k) clearance from the FDA for our single-source Nanox.ARC digital x-ray is a significant step forward along our US 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.”\n\n“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,” Mr. Poliakine concluded.\n\nThe 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.\n\nAbout Nanox:\n\nNanox, founded by the serial entrepreneur Ran Poliakine, is an Israeli corporation that is developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging service for all. For more information, please visit www.nanox.vision. \n\nForward-Looking Statements:\n\nThis press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of Nanox's research and development, manufacturing and commercialization activities with respect to its X-ray source technology and the ...