FDA Clears New Image Capabilities for Nanox’s Digital Tomosynthesis Systems

 NANO-X Imaging Ltd. (Nanox) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for TAP2D, a new cloud enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems.

The newly cleared enhancement capability provides radiologists with an additional, clear 2D view, generated from the digital tomosynthesis scan. The feature is designed to support evaluation while maintaining a smooth workflow for users. The additional view is automatically delivered within the existing clinical environment without adding complexity for clinicians or operators.

The Nanox.ARC and Nanox.ARC X are FDA-cleared, multi-source digital tomosynthesis systems that use advanced 3D imaging technology to provide enhanced diagnostic capabilities at a lower cost and radiation dose than traditional systems.

The Nanox.ARC systems’ software upgrades and new capabilities, such as TAP2D, can be added remotely to the Nanox.ARC systems, following this and future regulatory clearances.

“We are pleased to receive FDA clearance for TAP2D,” Nanox CEO/Acting Chairman Erez Meltzer said. “This clearance provides important regulatory insights as we work toward our goal of removing the adjunctive use in the United States, which would allow the Nanox.ARC to serve as a standalone primary imaging solution as it already does in Europe under our CE Mark certification. We remain focused on delivering innovations that elevate patient care and broaden access to high quality imaging around the world.”

Nanox plans to make the newly cleared enhancement software available to existing installations as part of its ongoing rollout of imaging improvements.

Nanox strives to deliver an integrated, end-to-end medical imaging and healthcare services platform. The company combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care. Nanox is attempting to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes.

The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provide access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT, which combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery.