(RTTNews) - Nano-X Imaging Ltd. (NNOX), Thursday announced that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA for its Nanox.ARC X, a new multi-source digital tomosynthesis system designed for general clinical use.
The clearance allows the Nanox.ARC X to produce tomographic images for a broad range of diagnostic applications, including musculoskeletal, pulmonary, intra-abdominal, and paranasal sinus indications in adult patients, as an adjunct to conventional radiography.
The Nanox.ARC X maintains the proprietary Nanox.SOURCE digital X-ray technology while introducing an upgraded single-unit design with a smaller footprint and plug-and-play one-day installation.
The system is compatible with standard X-ray rooms and infrastructure, and allows for remote software upgrades to add new capabilities pending future regulatory clearances.
"The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology," said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox.
He further added that, "We are committed to advancing access to 3D medical imaging globally, and the Nanox.ARC X reflects that mission by offering a more streamlined, scalable, and user-friendly solution."
Nanox will offer the Nanox.ARC X alongside the existing Nanox.ARC, expanding its portfolio of digital tomosynthesis systems to address varied healthcare environments and diagnostic needs.
The company aims to bring advanced imaging capabilities to a broader patient population, especially in underserved regions, as part of its overarching vision to support early detection, improved diagnosis, and a transition to preventive healthcare through AI-driven imaging and cloud-based solutions.
Currently, NNOX is trading at $4.98 up by 10.88 percent on the Nasdaq.
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