FDA Clears Emerging Digital Tomosynthesis System

Nanox.ARC X, a multi-source digital tomosynthesis system, has garnered 510(k) clearance from the Food and Drug Administration (FDA).

Adjunctive to conventional radiography, the Nanox.ARC X provides three-dimensional (3D) views for musculoskeletal and pulmonary imaging as well as intra-abdominal and paranasal sinus indications, according to Nanox, the developer of Nanox.ARC X. In addition to providing multiple image layers, the company said the Nanox.ARC X system reduces superimposition of structures that often hampers traditional X-rays.

Offering an integrated digital tomosynthesis unit with a streamlined design, Nanox maintained that the Nanox.ARC X platform has minimal infrastructure requirements and can be installed in a standard X-ray shielded room.

“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” noted Erez Meltzer, the chief executive officer 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.”