Nanox Imaging announced Friday that it has received U.S. Food and Drug Administration clearance for the single-source version of its digital X-ray technology.
The Israel-based startup has been working for months to obtain the regulatory greenlight for its new approach to legacy imaging. And it raised investor concerns earlier this year after the FDA sought to address deficiencies in its initial application. But after working closely with regulators to address those issues, the company has now gained authorization.
“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,” Chairman and CEO Ran Poliakine said April 2.
Nanox remains on track to start shipping systems in the fourth quarter of this year and into early 2022. Their goal is to finalize deployment of the first 15,000 Nanox.ARC systems before 2025.
Poliakine and colleagues said the company also continues to work on its application for FDA clearance of its multi-source imaging system and cloud technology. If OK’d, this version would be Nanox’s commercial imaging system set to eventually be deployed “broadly across the globe,” officials said.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.