Nanox in direct contact with FDA reviewers as startup negotiates approval of novel imaging system
Nanox Imaging is working closely with the U.S. Food and Drug Administration as the healthcare startup hopes to soon gain clearance for its novel X-ray system.
The Israel-based startup has been working for months to obtain regulatory approval for its Nanox.ARC technology it believes will disrupt radiology with a fresh take on legacy machinery. But it raised concerns from healthcare investors last month after reviewers found “deficiencies” in the application.
During a corporate earnings call Monday, CEO Ran Poliakine said Nanox has now submitted a “complete and comprehensive” response he believes fully addresses the agency’s remaining questions.
“Importantly, we are now in a direct contact with the FDA in addition to the third-party reviewer, and we believe that the process towards 510(k) clearance will go smoothly from here,” he told investors March 1.
Poliakine said his company is confident it will gain the FDA greenlight for both single- and multi-source versions of its imaging device in 2021. If granted, Nanox.ARC imaging procedures are expected to be covered by existing radiology reimbursement codes, he added. Nanox is additionally eyeing approval in Europe this year.
Founded in 2011, Nanox has developed proprietary imaging tech it says can achieve the same functionality as standard X-ray but at much lower production costs. They plan to operate under a “medical screening as a service” business model, providing systems at little to no cost to the provider and charging on a per-scan basis. Poliakine said Monday that their goal is not to compete with established industry players. Rather, Nanox wants to target smaller facilities that may not have access to imaging, including urgent care centers, outpatient clinics and rural areas. Officials hope to ship the first 1,000 systems in early 2022.
You can read more about the company’s four quarter earnings in Monday’s announcement and find a transcript of the call here.
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.