Nanox (NNOX) received additional information requests from FDA related to single-source version of Nanox.ARC
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Nanox (NASDAQ: NNOX) disclosed:
On January 30, 2021, in connection with the FDA’s review of its 510(k) premarket notification for the single-source version of the Nanox.ARC, NANO-X IMAGING LTD (the “Company”) received additional information requests from the FDA which, among other things, require the Company to address certain deficiencies and questions, including requests that the Company provide additional support regarding the intended use of the Nanox.ARC and the comparability of the Nanox.ARC to the predicate device. The Company plans to respond to these requests promptly. In addition, the Company will continue to optimize and develop features of the Nanox.ARC, and plans to submit an additional 510(k) premarket notification to the FDA with respect to the multiple-source Nanox.ARC and the Nanox.CLOUD during 2021. If cleared by the FDA and authorized by similar regulatory agencies in other jurisdictions, the Company is targeting shipment of 1,000 Nanox Systems by the end of the first quarter of 2022, with the goal to finalize deployment of the initial 15,000 Nanox Systems by the end of 2024.
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