![]() ![]() Specifically, while touting Nanox.ARC's regulatory and commercial prospects, Defendants concealed: (i) Nano-X's 510(k) application for the Nanox.ARC was deficient (ii) accordingly, it was unlikely that the FDA would approve the 510(k) application for the Nanox.ARC in its current form and (iii) as a result, Nano- X had overstated Nanox.ARC's regulatory and commercial prospects. The litigation alleges that Defendants misled investors concerning the 510(k) submission for Nanox.ARC. ![]() ![]() On June 17, 2021, Nano-X intrigued investors when it announced that it had submitted a 510(k) submission to the FDA to demonstrate the Nanox.ARC is marketed as safe and effective and substantially equivalent to a legally marketed device. Nano-X, a digital X-ray company, is developing the "Nanox.ARC," an imaging system that uses a purportedly novel X-ray source. Visit: Contact An Attorney Now: Imaging Ltd. (NASDAQ: NNOX) investors with significant losses to submit your losses now. December 6, 2021) - Hagens Berman urges Nano-X Imaging Ltd. San Francisco, California-(Newsfile Corp. ![]()
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