Nanox’s technology could considerably lower the costs of medical imaging systems. Credit: Jonathan Borba on Unsplash.

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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.