Shares of Nano-X Imaging Ltd. (NNOX) are gaining over 13% on Thursday morning after the medical imaging technology company announced that it has submitted 510(K) application to the U.S. Food and Drug Administration for its first version of multi-source Nanox.ARC.
NNOX is currently trading at $31.78, up $3.80 or 13.58%, on the Nasdaq.
"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 unmet medical need globally for a more accessible and cost-effective medical imaging solution. If cleared by the FDA, we believe our Nanox.ARC 3-D digital tomosynthesis can address this need."
Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021.
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