Nano-X Imaging Ltd. (NASDAQ: NNOX) stock gained by 14.90% in the current market trading. Nanox which is an Israeli company started by serial entrepreneur Ran Poliakine is working on a commercial-grade digital X-ray source that will be utilized in real-world medical imaging applications. Nanox believes that their innovative technology has the potential to dramatically lower the cost of medical imaging equipment, and it wants to work with world-class healthcare institutions and corporations to deliver cheap, early detection imaging to everyone.
What has happened?
NNOX stated today that it has filed a 510(k) premarket notification application to the US Food and Drug Administration (FDA) for its multi-source Nanox.ARC 3-D digital tomosynthesis system’s initial edition.
Upcoming Nanox.ARC versions will build on the initial iteration of the multi-source Nanox.ARC. The Nanox.ARC is a three-dimensional tomosynthesis imaging device that creates images of human body parts. With numerous alternately-switched X-ray tubes placed around the patient, the system is intended for ease of setup and operation.
Ran Poliakine, Chairman and Chief Executive Officer of Nanox stated,
The filing of a 510(k) for the first iteration of NNOX’s multi-source Nanox.ARC is a significant milestone. A more accessible and cost-effective medical imaging solution is a key unmet medical need throughout the world. NNOX thinks that their Nanox.ARC 3-D digital tomosynthesis, if approved by the FDA, will be able to meet this requirement. Mr. Poliakine continued, that as they progress toward future iterations of the multi-source Nanox, they are delighted to take this next step in our regulatory process. ARC, which will enable them to realize their worldwide goal by fulfilling current and future contracts with service providers and partnership agreements.
However, Nanox has gotten FDA clearance of its single-source Nanox Cart X-Ray System in April 2021.