Israel-based medical imaging technology company Nanox announces that it has been granted 510(k) clearance from the U.S. FDA for its single-source Nanox.ARC digital x-ray technology.
Ron Poliakine, Nanox chairman and CEO, calls the clearance an exciting development for the company. “Obtaining 510(k) clearance from the FDA for our single-source Nanox.ARC digital x-ray is a significant step forward along our U.S. regulatory pathway,” he says. “We remain on track to commence system shipments in the fourth quarter of 2021 and the first quarter of 2022, with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024.”
He adds, “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.”
The company remains on track and expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD in 2021. If cleared, the multi-source Nanox.ARC will be the company’s commercial imaging system that it expects to deploy broadly across the globe, Poliakine reveals.