Nano-X Imaging (NNOX) FDA Submission a 'Significant Regulatory Step' - Cantor Fitzgerald

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Nanox Announces FDA 510(k) Submission for First Version of Multi-Source Nanox.ARC

June 17, 2021 7:37 AM EDT

NEVE ILAN, Israel, June 17, 2021 (GLOBE NEWSWIRE) -- NANOX IMAGING LTD (NASDAQ: NNOX) (Nanox or the Company), an innovative medical imaging technology company, announced today that the Company has submitted a 510(k) premarket notification application to the U.S. Food and Drug Administration (FDA) for the first version of its multi-source Nanox.ARC 3-D digital tomosynthesis system.

The 510(k) submission for the first version of our multi-source Nanox.ARC is an important achievement, stated Ran Poliakine, Chairman and Chief Executive Officer of Nanox. There exists a significant... More