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Nano-X Imaging gets FDA clearance of multisource Nanox.Arc X-ray scanner

by John R. Fischer, Senior Reporter | May 04, 2023
X-Ray
Nanox.Arc (Photo courtesy of Nano-X Imaging)
Nano-X Imaging, based in Israel, has just scored FDA clearance for its multisource Nanox.Arc, a stationary X-ray system that reconstructs 2D images into 3D tomographic visualizations using novel, cold-cathode X-ray tubes instead of heat as a power source, making the scanner more affordable.

The solution is equipped with multiple alternatively-switched X-ray tubes arranged around the patient to produce scans of human body parts, with its cold-cathode technology digitally generating electrons to achieve the same effect as legacy scanners.

The company, which introduced its technology in 2019, plans to sell the solution with a pay-per-scan business model, and will work with the FDA to obtain other regulatory clearances to expand clinical indications, as well as build support for obtaining regulatory approval in other countries.

Nanox CEO Erez Meltzer says that as a cost-effective and scalable solution, Nanox.Arc shows great potential for improving care and operations in rural and low-income communities in the U.S. where facilities and equipment may be scarce.

"Compared with patients at urban hospitals, emergency department patients in rural hospitals are 7% less likely to receive advanced imaging, while patients at critical access hospitals are 18% less likely to have advanced imaging," he told HCB News.

The business model is facilitated by the integration of the Nanox.ARC and Nanox.Cloud, which can store images and facilitate access to radiologists from anywhere in the world to review them.

Nanox.Arc scans the patient and sends the data to the Nanox.Cloud, which activates the reconstruction algorithms, converting multiple 2D images into a single 3D tomo scan. This DICOM can then be transferred to the company's marketplace system via the cloud and accessed by a remote radiologist, who writes up a report and sends it back to the marketplace system, with the data transferred to the customer PACS system.

This pay-per-scan business model and use of a cloud-based solution enables tcustomers to avoid paying upfront capital expenditures or lease payments associated with traditional medical imaging systems.

Nano-X Imaging applied for clearance for Nanox.Arc in June 2021, soon after receiving approval for its single-source digital X-ray technology, Nanox Cart X-Ray System, which produces 2D CT and tomography scans.

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