Nanox Receives FDA 510(k) Clearance for TAP2D New Image Enhancement Capability for Nanox.ARC and Nanox.ARC X Systems
Rhea-AI Summary
Nanox (NNOX) announced FDA 510(k) clearance on February 3, 2026 for TAP2D, a cloud-enabled image enhancement for Nanox.ARC and Nanox.ARC X tomosynthesis systems. The feature generates a clear 2D view from a single tomosynthesis scan without additional radiation and integrates into existing workflows.
The clearance advances Nanox's regulatory pathway toward removing adjunct use in the US and enables remote software upgrades to existing installations as part of the company's rollout of imaging improvements.
Positive
- FDA 510(k) clearance granted for TAP2D on February 3, 2026
- 2D view generated from a single tomosynthesis scan without additional radiation exposure
- Capability is cloud-enabled and can be delivered remotely to existing Nanox.ARC installations
- Supports regulatory pathway toward removing adjunct use in the US, aligning with CE Mark standalone use in Europe
Negative
- Adjunct use still in place in the US; removing it remains a future objective rather than completed
- No financial metrics, commercial rollout timeline, or reimbursement details disclosed to indicate near-term revenue impact
- Clearance covers an image enhancement feature, not a full change to indicated primary use without further regulatory steps
News Market Reaction – NNOX
On the day this news was published, NNOX declined 6.25%, reflecting a notable negative market reaction. Argus tracked a trough of -17.1% from its starting point during tracking. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $14M from the company's valuation, bringing the market cap to $206M at that time. Trading volume was elevated at 2.8x the daily average, suggesting increased selling activity.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
NNOX slipped 0.37% despite positive FDA clearance, while peers in Medical Devices showed mixed moves (e.g., VMD up 4.03%, CATX up 21.27%, QSI down 0.9%, MGRM down 1.64%). This points to a stock-specific reaction rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 14 | Europe distribution deal | Positive | -0.7% | Exclusive Nanox.ARC distribution agreement across three Western Balkans countries. |
| Nov 25 | France distribution deal | Positive | +9.4% | Althea France partnership to commercialize CE-marked Nanox.ARC across France. |
| Nov 24 | AI software recognition | Positive | -5.3% | NICE recommends Nanox.AI bone tools for Early Value Assessment in UK NHS. |
| Nov 23 | Registered direct offering | Negative | -5.3% | $15M registered direct offering of 3,826,530 ordinary shares under Form F-3. |
| Nov 20 | Q3 2025 earnings | Positive | +13.9% | Q3 2025 results with $3.4M revenue, Vaso Healthcare IT acquisition and guidance. |
Recent history shows mixed reactions: positive commercial and regulatory updates often led to both gains and selloffs, while the November 2025 equity offering saw a negative, aligned move.
Over the last several months, Nanox has focused on expanding Nanox.ARC commercialization and enhancing its technology. European distribution deals in France and the Western Balkans, plus NICE support for Nanox.AI bone solutions, highlighted growing adoption and AI capabilities. Financially, Q3 2025 delivered $3.4M revenue with ongoing GAAP net losses and guidance for $35M 2026 revenue, followed by a $15M registered direct offering. Today’s FDA 510(k) clearance for TAP2D continues the theme of incremental regulatory and product milestones on top of this commercialization and financing backdrop.
Market Pulse Summary
The stock moved -6.3% in the session following this news. A negative reaction despite FDA clearance for TAP2D would fit Nanox’s history of occasional selloffs on otherwise constructive news, as seen with prior AI and distribution announcements. The company remains near its $2.64 52‑week low and below its $4.22 200‑day MA, reflecting a cautious backdrop shaped by ongoing GAAP net losses and a recent $15M direct offering. Investors have previously responded unfavorably to financing events, which can weigh on sentiment even when product or regulatory momentum continues.
Key Terms
510(k) clearance regulatory
digital tomosynthesis medical
ce mark regulatory
AI-generated analysis. Not financial advice.
This clearance enables the next phase of development aimed ultimately at removing the adjunct use in the US
The newly cleared capability provides radiologists with a 2D image generated directly from the tomosynthesis scan, enabling both 3D and 2D views from a single scan, without exposing the patient to any additional radiation
PETACH TIKVA, Israel – February 3 – NANO-X IMAGING LTD (“Nanox” or the “Company”) today announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for TAP2D, a new cloud enabled image enhancement capability for the Nanox.ARC and Nanox.ARC X digital tomosynthesis systems. This clearance marks an important step in Nanox's regulatory strategy to position its tomosynthesis systems as primary diagnostic solutions and advances the Company’s commitment to increased access to innovative medical imaging solutions.
The newly cleared enhancement capability provides radiologists with an additional, clear 2D view, generated from the digital tomosynthesis scan. The feature is designed to support evaluation while maintaining a smooth workflow for users. The additional view is automatically delivered within the existing clinical environment without adding complexity for clinicians or operators.
The Nanox.ARC and Nanox.ARC X are FDA cleared, multi-source digital tomosynthesis systems that utilize advanced 3D imaging technology to provide enhanced diagnostic capabilities at a lower cost and radiation dose than traditional systems.
The Nanox.ARC systems’ software upgrades and new capabilities, such as TAP2D, can be added remotely to the Nanox.ARC systems, following this and future regulatory clearances.
“We are pleased to receive FDA clearance for TAP2D,” said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox. “This clearance provides important regulatory insights as we work toward our goal of removing the adjunctive use in the United States, which would allow the Nanox.ARC to serve as a standalone primary imaging solution as it already does in Europe under our CE Mark certification. We remain focused on delivering innovations that elevate patient care and broaden access to high quality imaging around the world.”
Nanox plans to make the newly cleared enhancement software available to existing installations as part of its ongoing rollout of imaging improvements.
About Nanox
Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by delivering an integrated, end-to-end medical imaging and healthcare services platform.
Nanox combines affordable imaging hardware, advanced AI-based solutions, cloud-based software, access to remote radiology, health IT solutions, and a marketplace to enable earlier detection, improved clinical efficiency, and broader access to care.
Nanox’s vision is to expand the reach of medical imaging both within and beyond traditional hospital settings by providing a seamless solution from scan to interpretation and beyond. By leveraging proprietary digital X-ray technology, AI-driven analytics, and a clinically driven approach, Nanox aims to enhance the efficiency of routine imaging workflows, support early detection of disease, and improve patient outcomes.
The Nanox ecosystem includes Nanox.ARC, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; Nanox.AI, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; Nanox.CLOUD, a cloud-based platform for secure data management, storage, and advanced imaging analytics; Nanox.MARKETPLACE and USARAD Holdings, which provide access to remote radiology and cardiology experts and comprehensive teleradiology services; and Nanox Health IT, which combines deep healthcare IT expertise with leading technology partners to deliver RIS, PACS, AI, dictation, and secure infrastructure solutions that streamline workflows and support safer, more efficient care delivery.
By integrating imaging technology, AI, cloud infrastructure, clinical expertise, a marketplace, and health information technology, Nanox seeks to lower barriers to adoption, improve utilization, and advance preventive care worldwide. For more information, please visit www.nanox.vision
Forward-Looking Statements
This press release may contain forward-looking statements that are subject to risks and uncertainties. All statements that are not historical facts contained in this press release are forward-looking statements. Such statements include, but are not limited to, any statements relating to the initiation, timing, progress and results of the Company’s research and development, manufacturing, and commercialization activities with respect to its X-ray source technology and the Nanox.ARC, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies. In some cases, you can identify forward-looking statements by terminology such as “can,” “might,” “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “should,” “could,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on information the Company has when those statements are made or management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Factors that could cause actual results to differ materially from those currently anticipated include: risks related to (i) Nanox’s ability to complete development of the Nanox System; (ii) Nanox’s ability to successfully demonstrate the feasibility of its technology for commercial applications; (iii) Nanox’s expectations regarding the necessity of, timing of filing for, and receipt and maintenance of, regulatory clearances or approvals regarding its technology, the Nanox.ARC and Nanox.CLOUD from regulatory agencies worldwide and its ongoing compliance with applicable quality standards and regulatory requirements; (iv) Nanox’s ability to realize the anticipated benefits of the acquisitions, which may be affected by, among other things, competition, brand recognition, the ability of the acquired companies to grow and manage growth profitably and retain their key employees; (v) Nanox’s ability to enter into and maintain commercially reasonable arrangements with third-party manufacturers and suppliers to manufacture the Nanox.ARC; (vi) the market acceptance of the Nanox System and the proposed pay-per-scan business model; (vii) Nanox’s expectations regarding collaborations with third-parties and their potential benefits; (viii) Nanox’s ability to conduct business globally; (ix) changes in global, political, economic, business, competitive, market and regulatory forces; (x) risks related to the current war between Israel and Hamas and any worsening of the situation in Israel; (xi) risks related to business interruptions resulting from the COVID-19 pandemic or similar public health crises, among other things; and (xii) potential litigation associated with our transactions.
For a discussion of other risks and uncertainties, and other important factors, any of which could cause Nanox’s actual results to differ from those contained in the Forward-Looking Statements, see the section titled “Risk Factors” in Nanox’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. The reader should not place undue reliance on any forward-looking statements included in this press release. Except as required by law, Nanox undertakes no obligation to update publicly any forward-looking statements after the date of this press release to conform these statements to actual results or to changes in the Company’s expectations.
Contacts
Media Contact:
Ben Shannon
ICR Healthcare
NanoxPR@icrinc.com
Investor Contact:
Mike Cavanaugh
ICR Healthcare
mike.cavanaugh@icrhealthcare.com
FAQ
What did Nanox (NNOX) receive FDA clearance for on February 3, 2026?
How does TAP2D change imaging on Nanox.ARC and Nanox.ARC X systems (NNOX)?
Will TAP2D allow Nanox (NNOX) to use Nanox.ARC as a standalone primary imaging solution in the US?
Will existing Nanox.ARC installations receive the TAP2D enhancement and how is it delivered?
Does the FDA clearance of TAP2D expose patients to additional radiation for Nanox systems?
