NANO-X IMAGING LTD announced that its multi-source Nanox.ARC system has received CE (Conformité Européenne) mark certification, enabling its commercialization in Europe. This regulatory approval allows the system to generate tomographic images of human anatomy from a single tomographic sweep performed in recumbent positions of adult patients.
The CE mark represents the first major regulatory milestone for the Nanox.ARC Imaging System in the European market. This follows the general use FDA 510(k) clearance received in December 2024, marking a significant step in the global commercialization strategy for the Nanox.ARC system.
Erez Meltzer, Nanox Chief Executive Officer and Acting Chairman, stated that this certification, combined with recent FDA clearance, reinforces the company's commitment to advancing patient care globally. The Nanox.ARC system features a proprietary digital X-ray source and advanced tomosynthesis technology with a cold cathode, providing a comprehensive 3D view of the body.
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