Imaging disrupter Nanox on Friday announced the long-awaited news that it has received federal clearance for its novel single-source digital X-ray technology.
The U.S. Food and Drug Administration’s 510(k) clearance applies to the Nanox.ARC, the Israeli startup said April 2. Nanox has been working for months to gain this designation and was recently forced to push back its timeline after the FDA requested more information on its imaging system.
Ran Poliakine, chairman and chief executive officer of the company, celebrated the news on Friday.
“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,” Poliakine said in a statement. “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.”
Poliakine went on to say that his firm expects to submit a 510(k) application to the FDA for its multi-source Nanox.ARC and AI-powered cloud software Nanox.CLOUD later this year.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.