When the FDA approves biotech stocks’ products—as it did only recently from Nano-X Imaging’s (NASDAQ: NNOX) new product—it often means good news for the share price. And with Nano-X shares up over 68% in Monday’s trading, the FDA remains a bellwether of biotech gains.
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Nano-X brought in its Nanox.ARC X-ray system for the FDA’s consideration, and the FDA passed it right on through, giving the new imaging system 510(k) clearance. With that clearance in hand, Nano-X was free to start marketing the new system in the United States. It’s not quite the same as full clearance, but it gets Nano-X about where it wants to be. It allows the Nanox.ARC to be put in hospitals, clinics, and similar places for use.
This latest clearance was just another step in the road for Nano-X. A single-source device got approval back in April 2021, which suggests that approval should go smoothly from here. But Nano-X isn’t stopping at a single-source device, instead focusing its marketing efforts on the multi-source version. Either way, it would still have a dog in the hunt, and that meant good news for investors. With the multi-source system in place, though, it can now put together a series of two-dimensional images to create a three-dimensional approximation.
A look at the last five trading days for NNOX stock shows that the latest announcement put the stock on a whole new level. It was trading largely flat for most of that five-day period. This morning’s news, however, sent iNNOX vaulting straight up, where it would reach a whole new plateau.