Naxon imaging submitted its premarket application 510(k), which is the number one version of the digital multi-source tomosynthesis system, as per the 6-k figure submitted with the accredited U.S. Securities and Exchange Commission.
Nano mainly focuses on commercial-grade digital X-ray source development designed for real-world medical use in imaging applications.
The company further noted that this novel technology could substantially lower the price of the medical imaging system and aims to collaborate with various healthcare groups as well as companies, to deliver inexpensive and early detection services in healthcare imaging.
This Israeli startup expects to receive clearance from the Food and Drug Administration of America, for the original modality of multi-source Nanox ARC 3D digital tomosynthesis. In April 2021, the company also gained its federal clearance intended for digital single-source X-ray technology before sustaining major setbacks.
Upon this news, the stock of Nanox surged up to 15%, which is approximately $33 for a share before it settled for another 7% gain by the midday. Largely, the share price came down that year after it hit a major high at $72 in January.
Ran Poliakime, the CEO and Chairman, admitted that FDA report submission was a major achievement. He was quoted saying, “There is a massive unmet medical requirement worldwide for a better, cost-effective, and more accessible solution for medical imaging. If the FDA clears this, we believe the Nanox.ARC 3D digital tomosynthesis could address all the needs.”
However, Nanox also faced many hurdles during the time as one of the publicly traded companies. In February 2021, this imaging disruptor faced a major setback and was compelled to move back the timeline to ship its first consignment of 1000 Nanox.ARCs, for the first time, until the first quarter in 2022, after the FDA requested for more product-related information.
In May 2021, Poliakie announced that there is a predicament with third-party suppliers of the instrumental ceramic tube in the recent FDA-cleared technology. Nanox now expects to ship the systems on or before 2023.
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