FDA Clears Nanox.ARC Single-Source X-ray

The sci-fi inspired single-source digital X-ray device from Nanox – the Nanox.ARC – received 510(k) clearance from the U.S. Food & Drug Administration Friday.

The Nanox.ARC is a portable, light-weight X-ray system that scans the patient head-to-foot as he or she lies on the bed – much like the biobed seen in the Star Trek television series. It is intended for early detection via X-ray and other X-ray based imaging, including CT, mammography, fluoroscopy, and angiogram.

In a previous interview with Diagnostic Imaging, Ran Poliakine, chair and chief executive officer of the Israel-based company, said the ultimate goal is a 1x1x1 initiative – a preventive care solution that involves one screening per one symptomatic patient per year.

This FDA clearance is a significant step forward on their journey through the U.S. regulatory pathway, he said.

“We believe we are well positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world’s population who currently have limited to no meaningful access to imaging or the preventive screening that it offers.”

This clearance puts the company on track to begin shipments in both the fourth quarter of 2021 and first quarter of 2022. The intent is to complete the initial deployment of 15,000 systems by end-of-year 2024. In addition, he said, Nanox anticipates submitting a 510(k) application for its multi-source Nanox.ARC, as well as the Nanox.CLOUD later this year.

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