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Nanox stock drops following FDA hold on 510(k) for multi-source, digital tomosynthesis solution

by John R. Fischer, Senior Reporter | August 24, 2021
Business Affairs CT X-Ray

“There is not one scientific paper or submission that would back up any of these claims,” according to the Citron report, which described the company’s claims as a "farce". “As a matter of fact, we have not even seen proof of the product and have only seen a mock-up drawing of what this machine is supposed to look like.”

Despite the success of the company’s IPO, which was set up in August 2020, the report resulted in a net loss for the company of over $11 million in the third quarter of the 2020.

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The company earlier this year scored FDA clearance for its single-source Nanox.Arc digital X-ray technology. Intended to be a less expensive alternative to legacy X-ray machines, Nanox.Arc is designed to generate 2D CT and tomography scans using the company’s digital source. This could potentially expand access to imaging for two-thirds of the world where it is lacking, decrease waiting times and identify serious and chronic illnesses early.

Nanox also recently acquired Zebra Medical Vision and USARAD for $230 million together. Zebra Medical will embed a scalable cloud infrastructure into Nanox’s imaging equipment to make scanning more accessible and affordable globally. USARAD, a U.S.-based teleradiology provider with over 300 certified radiologists, meanwhile, will make Nanox a provider of subspecialty radiology and teleradiology.

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