Nano X Imaging Jumps To 4-Month High On FDA Green Light For X-Ray System: Retail In Frenzy

Shares of Nano-X Imaging Ltd. surged by as much as 10% on Thursday, reaching levels not seen since August before pulling back slightly. 

The medical imaging device company announced it had received 510(k) clearance from the U.S. Food and Drug Administration for its Nanox.ARC, a stationary X-ray system designed to produce tomographic images for a range of general use cases. 

These include imaging of the human musculoskeletal system, lungs, abdomen, and sinuses, serving as an adjunct to conventional radiography for adult patients.

“With this FDA clearance, we can now offer U.S. healthcare providers significantly broader imaging capabilities that are akin to commonly used traditional X-ray devices,” said Erez Meltzer, CEO and Acting Chairman of Nano-X. 

“Our mission is to provide healthcare practices with a transformative imaging advantage with the Nanox.ARC - an accessible, cost-effective solution that not only provides advanced diagnostic imaging capabilities but also elevates overall patient care.”

The company is optimistic that the new FDA-cleared indications will facilitate the broader commercial expansion of Nanox.ARC in the U.S., where the system is already deployed in multiple healthcare facilities across seven states.

NNOX sentiment and message volume on Dec 5 as of 11:45 am ET | Source: Stocktwits

Retail sentiment for Nano-X on Stocktwits has exploded, with over 16,000 followers turning ‘extremely bullish’ in response to the news. 

One user said they have “been waiting for this moment for four years.”

Another user speculated on the possibility of acquisition based on the regulatory approval.

The company is also generating buzz due to its attendance at a Cantor Fitzgerald meeting in New York on Thursday. 

Despite a recent downgrade, with Cantor lowering its price target from $14 to $11, the brokerage maintained an ‘Overweight’ rating following Nano-X’s third-quarter (Q3) results. 

Nano-X reported $3 million in Q3 revenue, below consensus estimates, but revealed notable growth in teleradiology services and AI solutions. Analysts remain optimistic about expanding U.S. deployments and the potential for additional indications and next-gen devices.

NNOX shares have remained nearly flat year-to-date.

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