par John R. Fischer
, Senior Reporter | June 23, 2021
Nanox Imaging is pursuing clearance in the U.S. for the first version of its multisource Nanox.ARC 3-D digital tomosynthesis system, which is equipped with multiple alternatively-switched X-ray tubes arranged around the patient to produce scans of human body parts.
This month, the company submitted a 510(k) premarket notification application to the FDA.
“There exists a significant unmet medical need globally for a more accessible and cost-effective medical imaging solution," said Ran Poliakine, chairman and CEO of Nanox, in a statement. "If cleared by the FDA, we believe our Nanox.ARC 3-D digital tomosynthesis can address this need.”
Quest Imaging Solutions provides all major brands of surgical c-arms (new and refurbished) and carries a large inventory for purchase or rent. With over 20 years in the medical equipment business we can help you fulfill your equipment needs
The announcement of its premarket notification application sent stocks soaring Thursday morning by over 15% on NASDAQ, with shares currently hovering around $31. Last September, Nanox stock values plummeted
following criticism and lawsuits over the efficiency of Nanox.ARC, compared to conventional CT scanners.
The single-source Nanox Cart X-ray System received FDA clearance
in April. Designed to produce 2D CT and tomography scans with Nanox’s digital source, that system is intended as a less expensive alternative to legacy X-ray machines. The company expects it to potentially increase access for two-thirds of the world where imaging and screening are lacking, decrease waiting times and help identify serious or chronic illnesses in early stages.
Nanox introduced its X-ray technology
in 2019. Based on a proprietary silicon MEMs semiconductor technology and developed over 15 years, the commercial-grade digital X-ray technology is able to produce electrons without the use of heat and perform at the same level as legacy X-ray sources.
The company plans to produce other versions of Nanox.Arc following its first model.
Nanox did not respond for comment.