Shares of Nano-X Imaging (NASDAQ:NNOX) are surging in Monday’s pre-market activity after the Israeli medical imaging disruptor announced that it had received a critical regulatory greenlight for its digital x-ray technology. NNOX stock was up more than 60% at 7 a.m. Eastern.
The news of Nano-X’s 510(k) clearance for its single-source Nanox.ARC technology comes a month after the firm said it was in direct communication with the U.S. Food and Drug Administration in response to the agency’s questions concerning the technology. At the time, CEO Ran Poliakine said he expected commercial shipments to start in the fourth quarter of 2021.
Today’s announcement also sets the stage for similar 510(k) applications to the FDA later this year for Nano-X’s multi-source Nanox.ARC and the Nanox.CLOUD products.
NNOX technology is poised to disrupt traditional x-ray technology, with its analog mechanism. By digitizing the traditional process, Nano-X is able to eliminate much of the bulky structures of traditional imaging equipment while delivering lifesaving, accurate results in a less-expensive platform that’s built for scale.
The appeal of NNOX stock is that this key innovation can capture patient demand from demographics that have been neglected due to financial or geographic challenges.
NNOX Stock Pops As It Scales Chip Production
NNOX stock has lost 7.8% of its value in the last month despite promising developments in its technology development. In early March, the company announced plans to scale up its semiconductor fabrication plant in South Korea, currently in the planning stage, due to increased demand for the Nanox.ARC systems.
That decline came after investors seemingly dismissed September reports by short-seller Muddy Waters that Nano-X “almost certainly used somebody else’s chest images to try to make its ARC machine look real.” Muddy Waters’ report followed accusations by Citron Research that the “project appears to be nothing more than a complete stock promotion.”
After several days of declines in the wake of that report, NNOX started to climb, gaining 242% through early February.
The company’s technology and its promise to both lower imaging costs and capture patient demand from demographics that have been neglected due to financial or geographic challenges, caught the eye of InvestorPlace contributor Josh Enomoto last month.
“I’m really intrigued with the profound technology of transitioning medical imaging from anachronistic analog to groundbreaking digital. Take a measured wager on NNOX stock if you like but do make sure to keep the powder keg dry,” he wrote.
On the date of publication, Robert Lakin did not have (either directly or indirectly) any positions in the securities mentioned in this article.
InvestorPlace contributor Robert Lakin is a veteran financial writer and editor, following fintech, agtech and property tech startups.