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Nano-X Imaging Receives Go Ahead from FDA for Single Source Digital X-Ray

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Shares of Nano-X Imaging Ltd. traded 17% higher after the company reported that the FDA has granted 510(k) approval for its single source ARC digital x-ray.

Medical imaging technology company Nano-X Imaging Ltd. (NNOX:NASDAQ) announced that its "single-source Nanox.ARC digital x-ray technology has received 510(k) clearance from the U.S. Food and Drug Administration (FDA)."

Nano-X Imaging's Chairman and CEO Ran Poliakine commented, "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...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 continued, "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 indicated that in addition to receiving the FDA Clearance for its single-source Nanox.ARC digital x-ray, it also is continuing its development efforts and remains on track with its plans to submit an additional 510(k) application this year to the FDA for its multi-source Nanox.ARC and the Nanox.CLOUD. The firm stated that if FDA approval is received for the multi-source Nanox.ARC, its strategy will be to broadly deploy that commercial imaging system worldwide.

Nano-X Imaging Ltd. is headquartered in Neve Ilan, Israel, and is engaged in the development of commercial-grade digital X-ray source for practical applications for use in real-world medical imaging. The company noted that its technology offers the potential for great cost reductions in imaging systems. The firm stated that it is seeking collaborative opportunities with world-leading healthcare organizations and companies to deliver affordable, early detection imaging services globally. The company intends to roll out a mass deployment of its imaging systems which it believes will aid in driving early detection preventive healthcare for all who need it setting a new standard of care.

Nano-X Imaging began the day with a market capitalization of around $1.9 billion with approximately 46.1 million shares outstanding and a short interest of about 4.0%. NNOX shares opened nearly 54% higher today at $63.61 (+$22.28, +53.91%) over the previous trading day's closing price of $41.33. The stock has traded today between $48.26 and $64.00 per share and is currently trading at $49.00 (+$7.67, +18.56%).


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