Nanox single-source digital X-ray gets FDA 510(k) clearance

por John R. Fischer, Senior Reporter | April 07, 2021
CT X-Ray
Nanox has gotten FDA approval for its single-source Nanox.ARC digital X-ray technology
Nano-X Imaging has received the nod from the FDA for its single-source Nanox.Arc digital X-ray technology.

The X-ray System is designed to produce 2D CT and tomography scans with Nanox's digital source, and is touted as a less expensive alternative to legacy X-ray machines. It expects the system to potentially increase access for two-thirds of the world where imaging and screening are lacking, as well as decrease waiting times and help detect serious or chronic illnesses in early stages.

“Based on timing for obtaining regulatory and additional clearances, we're on track to commence system shipments in the fourth quarter of 2021 and into the first quarter of 2022 with the goal of finalizing deployment of the initial 15,000 Nanox.ARC systems by the end of 2024,” Ran Poliakine, chairman and chief executive officer of Nanox, told HCB News.
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The company also expects to submit a 510(k) application to the FDA for its multi-source Nanox.Arc. The 3D Digital Tomosynthesis whole body scanners include multiple single source tubes and can be used for a variety of procedures. Nanox plans to continue to optimize and develop further features for it before submitting a 510(k) application in 2021.

It also plans to submit an additional one at the same time for its Nanox.CLOUD solution. "Once an image is taken by one of our Nanox.ARC scanners, it is then sent to the cloud, where it can be viewed, stored, matched with a radiologist anywhere in the world, reviewed using diagnostic AI, and sent for billing and reporting. Our Innovative MSaaS business model is enabled by the integration between the Nanox.ARC and Nanox.Cloud," said Poliakine.

He adds that Nanox.CLOUD comes with little to no upfront CAPEX cost and removes the burden of large upfront capital expenditure or lease payments.

Nanox came under fire in September when online stock commentator Citron Research alleged the company did not show any evidence to compare the efficacy of Nanox.Arc with conventional CT scanners. It also accused Nanox of making up false distribution agreements with made-up customers. The accusations resulted in lawsuits and a drop in stock value.

The Citron report also pointed out that the company's 510(k) application indicated the technology is similar to previously cleared devices already on the market.

Nanox denied the claims in the suit. “We look forward to demonstrating our digital X-ray technology in a range of 2D and 3D medical imaging procedures at this year’s virtual Radiology Society of North America 2020 meeting later this month, and intend to make these materials available to our investors and global stakeholders so they can join and witness our technology,” said Poliakine at the time.

The company also suffered an $11.1 million net loss in Q3 2020, due to increased spending on research and development and sales and marketing. A $5.3 million increase in general and administrative expenses from 2019 to 2020 also contributed to the loss.

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