What happened

Shares of Nano-X Imaging (NNOX -0.30%) (Nanox) were skyrocketing 28.7% higher as of 10:34 a.m. EDT on Monday. The huge jump came after the company announced that the U.S. Food and Drug Administration (FDA) awarded 510(k) clearance to its single-source Nanox.ARC digital X-ray technology.

So what

FDA clearance means that Nanox has a green light to market its game-changing X-ray system. Nanox CEO Ran Poliakine said that this was "a significant step forward" for his company.

Healthcare professional showing an X-ray image on a tablet to another person

Image source: Getty Images.

Nanox's X-ray devices are fully digital and eliminate the need for conventional X-ray tubes. This means that the company's systems are smaller and require much less energy to operate. They're also a lot less expensive than current X-ray devices.

These advantages could be huge as Nanox begins to market its technology. Poliakine said, "We believe we are well positioned to achieve our goal of democratizing medical imaging and expanding the market to the roughly two-thirds of the world's population who currently have limited or no meaningful access to imaging or the preventative screening that it offers."

Now what

Nanox expects to begin shipping its single-source systems in the fourth quarter of 2021 and the first quarter of 2022. The company thinks that it will be able to place 15,000 initial systems by the end of 2024. Another key catalyst for the life sciences stock could also be on the way: Nanox hopes to submit for FDA clearance for its multisource Nanox.ARC system this year.