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 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.”
The first version of the multi-source Nanox.ARC will be followed by future Nanox.ARC versions. Nanox.ARC is a 3-D tomosynthesis imaging system that produces scans of a human body part. The system is being designed for easy setup and operation with multiple alternately-switched X-ray tubes arranged around the patient.
“We are excited to take this next step in our regulatory process as we move toward future versions of the multi-source Nanox.ARC, which will fulfill current and future contracts with service providers and collaboration agreements and allow us to achieve our global vision,” added Mr. Poliakine.
Nanox received FDA clearance of its single source Nanox Cart X-Ray System in April 2021.