Nanox Imaging has received 510(k) clearance from the United States Food and Drug Administration (FDA) for TAP2D, a new cloud-enabled image enhancement capability designed for its Nanox.ARC and Nanox.ARC X digital tomosynthesis systems. The regulatory clearance marks a key milestone in the company’s strategy to strengthen its position in the US imaging market and advance toward removing the adjunctive-use limitation on its systems.

The TAP2D capability enables radiologists to generate a clear 2D image directly from a tomosynthesis scan, allowing both 3D and 2D views from a single acquisition without exposing patients to additional radiation. The feature is automatically integrated into existing clinical workflows, providing enhanced evaluation support without adding operational complexity for clinicians or technicians.

The FDA clearance supports the company’s broader regulatory objective of positioning its multi-source digital tomosynthesis systems as standalone primary diagnostic solutions in the United States, similar to their status in Europe under CE Mark certification. The company plans to roll out the newly cleared software enhancement to existing Nanox.ARC installations as part of ongoing system upgrades, with remote deployment enabled following regulatory approvals.

Nanox.ARC and Nanox.ARC X are FDA-cleared, multi-source digital tomosynthesis systems that leverage advanced 3D imaging technology to deliver enhanced diagnostic capabilities at lower cost and radiation exposure compared to traditional imaging systems. The systems are designed for scalability, ease of use and broader accessibility.

Commenting on the development, Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox, said, “The clearance provides important regulatory insight as the company works toward expanding the ARC system’s role as a standalone imaging solution in the US market. Nanox remains committed to advancing innovations that improve patient care and expand access to high-quality medical imaging globally.”

Nanox operates an integrated medical imaging ecosystem that combines hardware, AI-based analytics, cloud infrastructure and remote radiology services. Its portfolio includes Nanox.AI for AI-driven imaging analysis, Nanox.CLOUD for secure data management, Nanox.MARKETPLACE and USARAD Holdings for teleradiology services and Nanox Health IT solutions that support streamlined clinical workflows.

Through the integration of imaging technology, artificial intelligence, cloud-based platforms and clinical expertise, Nanox aims to enhance early disease detection, improve workflow efficiency and expand access to preventive healthcare worldwide.