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April 5, 2021

FDA grants 510(k) clearance to Nanox’s digital X-ray system

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Israeli company NANO-X IMAGING’s (Nanox) single-source Nanox.ARC digital x-ray technology.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Israeli company NANO-X IMAGING’s (Nanox) single-source Nanox.ARC digital x-ray technology.

Nanox focuses on developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications.

The company noted that its novel technology could considerably lower the costs of medical imaging systems and intends to partner with healthcare groups and companies to offer inexpensive, early detection imaging service.

Nanox chairman and CEO Ran Poliakine said: “Obtaining 510(k) clearance from the FDA for our single-source Nanox.ARC digital x-ray is a significant step forward along our US regulatory pathway.

“We remain on track to commence system shipments in the fourth quarter of 2021 and the first quarter of 2022 with the goal of finalising deployment of the initial 15,000 Nanox.ARC systems by the end of 2024.

“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 or no meaningful access to imaging or the preventative screening that it offers.”

Furthermore, the company plans to submit a 510(k) application to the FDA for its multi-source Nanox.ARC as well the Nanox.CLOUD, this year.

On obtaining clearance, Nanox anticipates making the multi-source Nanox.ARC a commercial imaging system to be deployed widely across the world.

In July last year, Nanox secured another $59m in funding to mainly fund the global launch of the in-hospital imaging device Nanox.ARC. Including this investment, the company has raised a total of $110m in the Series B funding round since November 2019.

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