Nano-X Imaging Secures FDA 510(k) Clearance for TAP2D Image Enhancement on Nanox.ARC Systems

Nano-X Imaging ( (NNOX) ) has issued an announcement.

On February 3, 2026, Nano-X Imaging announced it had received U.S. FDA 510(k) clearance for TAP2D, a new cloud-enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems. TAP2D generates a clear 2D image directly from a single 3D tomosynthesis scan, enabling radiologists to access both 3D and 2D views without additional radiation exposure or workflow complexity, and can be deployed as a remote software upgrade to existing Nanox.ARC installations. The clearance is a key milestone in Nanox’s regulatory strategy to move its tomosynthesis platforms from adjunct use toward a primary diagnostic role in the U.S., aligning them more closely with their standalone status in Europe, and is expected to support broader adoption of the company’s lower-cost, lower-dose imaging systems as part of its ongoing rollout of imaging improvements.

The most recent analyst rating on (NNOX) stock is a Hold with a $2.50 price target. To see the full list of analyst forecasts on Nano-X Imaging stock, see the NNOX Stock Forecast page.

Spark’s Take on NNOX Stock

According to Spark, TipRanks’ AI Analyst, NNOX is a Neutral.

The score is primarily held down by weak financial performance—negative gross profit, large ongoing losses, and sustained cash burn—despite a low-debt balance sheet. Technicals also remain soft with the stock below key moving averages and negative MACD. Positive earnings-call guidance and expansion initiatives provide some upside, but are tempered by continued losses and regulatory/expense headwinds.

To see Spark’s full report on NNOX stock, click here.

More about Nano-X Imaging

Nano-X Imaging Ltd. (Nanox), listed on Nasdaq under the ticker NNOX, operates in the medical imaging and healthcare technology sector, focusing on an integrated end-to-end platform that spans affordable imaging hardware, AI-based diagnostic tools, cloud-based software, remote radiology services, and health IT solutions. Its ecosystem includes the Nanox.ARC multi-source 3D digital tomosynthesis imaging system, Nanox.AI algorithms for CT interpretation, Nanox.CLOUD for secure data management and analytics, teleradiology and marketplace services via USARAD Holdings and Nanox.MARKETPLACE, and Nanox Health IT offerings such as RIS, PACS, AI and dictation tools aimed at streamlining imaging workflows and enabling earlier disease detection.

Average Trading Volume: 1,662,111

Technical Sentiment Signal: Sell

Current Market Cap: $174.1M

Find detailed analytics on NNOX stock on TipRanks’ Stock Analysis page.