Nano-X Imaging Ltd. (NASDAQ: NNOX) rose sharply in early Monday trading. The company’s stock is seeing high social media interest on Monday. The interest in Nano-X Imaging follows the company announcing Friday that it received 510(k) clearance from the U.S. Food and Drug Administration for its single-source Nanox.ARC digital x-ray technology.
Said CEO Ran Poliakine, “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 finalizing 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,” Poliakine concluded.
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.
The Israeli-based Nanox is developing a commercial-grade digital X-ray source designed to be used in real-world medical imaging applications. Nanox believes that its novel technology could significantly reduce the costs of medical imaging systems and plans to seek collaborations with world-leading healthcare organizations and companies to provide affordable, early detection imaging service for all.
NNOX shares $15.70, or 38%, to $57.03.