Israeli medical imaging technology company NANO-X Imaging Ltd. (Nasdaq: NNOX) has announced that its single-source Nanox.ARC digital x-ray technology has received clearance from the US Food and Drug Administration (FDA).
NANO-X chairman and CEO Ran Poliakine said, "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."
He added, "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 worldwide.
NANO-X has developed a lightweight, mobile CT scanner, and has a business model based on a unique medical screening as a service (MSaaS) to allow wide distribution and accessibility, and charging health providers with a pay-per-scan service model. Based in Neve Ilan near Jerusalem, the company was founded in 2012 by Poliakine. Nanox raised $137 million before its IPO last year from investors including Korea's SK Telecom, Industrial Alliance, Yozma Korea, Foxconn, Fuji, and Jin Ji Full. NANO-X held its IPO in August at a valuation of $800 million and currently has a market cap of $1.9 billion.
Published by Globes, Israel business news - en.globes.co.il - on April 5, 2021
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