- FDA grants Nanox (NNOX, Financial) expedited 510(k) clearance for the Nanox.ARC X imaging system.
- New system offers advanced 3D visualization with reduced installation complexity.
- Nanox.ARC X set for commercial release alongside Nanox.ARC in late 2025.
Petah Tikva, Israel, April 17, 2025 - In a significant regulatory development, Nanox Imaging Ltd. (NASDAQ: NNOX) announced that it has received FDA 510(k) clearance for its innovative Nanox.ARC X multi-source digital tomosynthesis system. This clearance was obtained in an impressive timeline of less than 30 days, underscoring the robustness of the submission and the clean safety profile of the technology.
The Nanox.ARC X system, which employs the company's proprietary digital Nanox.SOURCE technology and advanced tomosynthesis, provides enhanced 3D body imaging capabilities. This system has the potential to revolutionize the way healthcare providers conduct tomographic imaging across musculoskeletal, pulmonary, intra-abdominal, and paranasal sinus applications in adults.
The Nanox.ARC X is designed for a smooth integration into medical facilities, featuring a streamlined single-unit design with a significantly reduced footprint. It offers a 'plug and play' one-day installation process, operating on standard power (110v/230v 16A), and a cables-free design for improved user and patient safety. This feature suite allows for seamless deployment in diverse healthcare settings, especially those with space constraints.
Erez Meltzer, the CEO and Acting Chairman of Nanox, remarked on the achievement, stating, “The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology, bringing us closer to our mission to make advanced medical imaging accessible to more patients worldwide.”
Nanox is preparing to offer the Nanox.ARC X system commercially later in 2025, alongside its existing Nanox.ARC system. This dual offering aims to cater to a wider range of healthcare facilities by providing tailored imaging solutions. For more information on Nanox's full suite of technologies, please visit their website at www.nanox.vision.
