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>>> Nano-X Imaging Drops After FDA Seeks More Data on New X-Ray System


Nano-X Imaging fell after the FDA requested additional information concerning the company's application for its portable X-ray system.


The Street

8-19-21

by VIDHI CHOUDHARY


https://www.thestreet.com/investing/nano-x-drops-after-fda-seeks-more-data-on-portable-x-ray-device?puc=yahoo&cm_ven=YAHOO


Shares of Nano-X Imaging (NNOX) - Get Nano X Imaging LTD Report dropped Thursday after the U.S. Food and Drug Administration sought additional information on the Israeli medical-tech company's portable X-ray system.

Shares of the Neve Ilan, Israel, company at last check fell 8.4% to $21.70.

Stocks Fail to Hold Momentum as Fed Taper Talk Too Much for Wall Street

"The submission file is placed on hold pending a complete response to the FDA's list of deficiencies," the company said in a regulatory filing made to the Securities and Exchange Commission.

Nano-X Imaging plans to respond by the due date, which is 180 days from Aug. 12.

The company also said that it expected to continue to optimize and develop further features of the system, called Nanox.ARC.

Nano-X also said in the filing that it's considering submitting an application for the latest model of the multisource Nano.ARC system.

That first version has FDA clearance, and the company said the new model would benefit from the FDA's feedback.

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