Nanox receives FDA clearance for Nanox.ARC X imaging system for general use

Medical imaging technology company Nano-X Imaging Ltd (Nanox) (Nasdaq:NNOX) announced on Thursday that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its new digital tomosynthesis system, Nanox.ARC X.

This clearance allows for general use in tomographic imaging of musculoskeletal, pulmonary, intra-abdominal and paranasal sinus regions, adjunctive to conventional radiography in adults.

Nanox.ARC X builds on the proprietary cold cathode Nanox.SOURCE technology to produce enhanced three-dimensional imaging, minimising structure overlap typical in 2D X-rays. The system features a compact, single-unit design with a simplified 'plug and play' installation process suitable for standard X-ray shielded rooms.

Operating on standard electrical power, Nanox.ARC X includes a cables-free configuration to support safety, maintenance and hygiene. The system's infrastructure flexibility and remote upgrade capabilities aim to broaden adoption across healthcare environments with space limitations.

Nanox will offer the Nanox.ARC X later this year alongside the existing Nanox.ARC, expanding its imaging portfolio to address a wider range of clinical needs.



Published in M2 EquityBites on Thursday, 17 April 2025
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