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FDA clears Nanox.ARC X for general imaging use

por Gus Iversen, Editor in Chief | April 23, 2025
X-Ray
Nanox.ARC X
Nanox has received FDA clearance for Nanox.ARC X, which produces tomographic images for general clinical use, including musculoskeletal, pulmonary, intra-abdominal, and paranasal sinus assessments in adult patients, alongside conventional radiography.

The Nanox.ARC X is the latest version of the Petach Tikva, Israel-based company's multisource digital tomosynthesis technology. It retains the proprietary Nanox.SOURCE and tomosynthesis platform from the original Nanox.ARC, incorporating a cold cathode to produce layered 3D images that reduce structural overlap common in traditional 2D X-rays.

According to the company, the updated system introduces a compact, integrated design with simplified installation that can be completed in a single day. It is compatible with standard X-ray shielded rooms and operates on conventional electrical power, with a cable-free setup intended to streamline cleaning and maintenance.
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Nanox plans to support the system with software upgrades that can be deployed remotely, pending future regulatory clearances.

“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” said Erez Meltzer, CEO and acting chairman of Nanox. “By integrating our proprietary digital technology in this new imaging system, we’re making it easier for healthcare providers to adopt digital 3D imaging.”

The Nanox.ARC X is expected to launch later this year, joining the current Nanox.ARC in the company's imaging portfolio.

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