Nanox to Launch FDA-Cleared Nanox.ARC X and Present development of new AI innovations at RSNA 2025 Annual Meeting

Rhea-AI Summary

Nanox (Nasdaq: NNOX) will launch and demonstrate the FDA 510(k)-cleared Nanox.ARC X multi-source digital tomosynthesis system at RSNA 2025 (Nov 30–Dec 4, 2025) in Chicago. The Nanox.ARC X received FDA clearance in April 2025 for musculoskeletal, pulmonary, intra-abdominal and paranasal indications and is described as lower cost and lower radiation than CT. Live demos run every 30 minutes at Booth #3914. The company will also present clinical data, unveil a pulmonary nodule AI under development, and introduce two new AI tools for aortic valve calcification and body composition measurement.

Positive

• FDA 510(k) clearance for Nanox.ARC X in April 2025
• Live demos every 30 minutes at RSNA Booth #3914 during Nov 30–Dec 4, 2025
• New pulmonary nodule AI under development as future Nanox.ARC X component
• Two additional AI innovations for aortic valve calcification and body composition

Negative

• None.

Insights

Medical imaging product and regulatory analyst

FDA-cleared Nanox.ARC X launch and AI pipeline demos at RSNA are operationally positive, highlighting commercialization and clinical validation steps.

Nano‑X presents the Nanox.ARC X, an FDA 510(k)-cleared multi-source digital tomosynthesis system, to clinicians and potential partners at RSNA 2025 with live demos and clinical posters; this advances the device from regulatory clearance toward market exposure and clinician evaluation. The company also showcases its AI portfolio and announces development of a pulmonary nodule AI component plus two standalone AI tools for aortic valve calcification and body composition, which integrate with its imaging hardware.

The principal dependencies are adoption by clinical sites, demonstration of real-world workflow fit, and successful clinical validation beyond the disclosed poster and demo sessions; regulatory clearance alone does not guarantee reimbursement, purchase decisions, or scale. Key near-term risks include user acceptance, integration with existing radiology workflows at places attending RSNA, and the unknown clinical performance of the AI tools under development.

Watch for follow-ups over the next 3–12 months: uptake signals from demonstration bookings and partnership announcements at RSNA and immediately afterward, any published clinical performance metrics or peer-reviewed data tied to the RSNA poster/session on November 30, 2025–December 4, 2025, and formal product availability or pilot agreements disclosed by the company.

• Live demonstrations of Nanox.ARC X to be featured at RSNA booth (3914, South Hall Level 3) every 30 minutes
• Innovation Theater presentation to highlight development of pulmonary nodule AI solution, as future component of Nanox.ARC X; Dec 2 at 11:00am (Innovation Theater, Booth # 3316, South Hall A)
• Poster presentation: “Applications of Digital Tomosynthesis in the Musculoskeletal System” (Learning Center, East Level 3)
• Dr. Lawrence Tanenbaum to host cocktail event featuring discussion about the future of radiology and AI; Dec 1 at 5:30pm (VU Rooftop Bar, Hilton Garden)

PETACH TIKVA, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company”, Nasdaq: NNOX), an innovative medical imaging technology company, today announced that it will showcase its Nanox.ARC X multi-source digital tomosynthesis system and highlight development of new solutions for its AI portfolio at the Radiological Society of North America (RSNA) 2025 Annual Meeting, being held November 30 - December 4, 2025 in Chicago, IL.

The Nanox.ARC X, an AI-ready, multi-source digital tomosynthesis system that makes advanced 3D imaging possible in more places at significantly lower cost and radiation dose than CT, received FDA 510(k) clearance in April 2025 for general use, including musculoskeletal, pulmonary, intra-abdominal and paranasal indications. At RSNA 2025, attendees will have their first opportunity to see live demonstrations of the system. Nanox will showcase its full end-to-end imaging solution, which includes the Nanox.ARC X and its suite of FDA-cleared, AI-powered software that analyzes routine CT scans to identify early signs of chronic conditions.

Live demonstrations of the Nanox.ARC X will be featured at Booth #3914 (South Hall Level 3) every 30 minutes, and the Company will present clinical data supporting digital tomosynthesis across multiple applications. Nanox will also announce a pulmonary nodule AI solution currently under development as a future component of the Nanox.ARC X, as well as two new standalone AI innovations for aortic valve calcification measurement and body composition measurements.

“We are excited to unveil the Nanox.ARC X system to the radiology community for the first time. The system bridges the gap between conventional X-rays and CT scans, bringing advanced 3D imaging to everyday care settings where it hasn’t been practical before,” said Erez Meltzer, CEO and Acting Chairman of Nanox. “We will also be highlighting our expanding AI portfolio, featuring two new AI innovations in development. We’re delivering on our vision to leverage our AI and proprietary digital X-ray source technology to make advanced medical imaging accessible to more patients, in more places.”

More details about Nanox’s RSNA 2025 presentations and events are as follows.

RSNA Innovation Theater Presentation: Nanox: From Vision to Reality – AI and Digital Tomosynthesis in Pulmonary Nodule Detection

• Presenter: Orit Wimpfheimer, MD (Chief Medical Officer of Nanox)
• Location: Innovation Theater, Booth 3316, South Hall A
• Day/Time: December 2, 11:00-11:20 am CT

Educational Exhibit Poster Presentation: Applications of Digital Tomosynthesis in the Musculoskeletal System

• Authors: Nogah Shabshin, MD, Mor Armoni, Yotam Kimmel, Guy Yoskovitz, Yael S. Schiffenbauer, PhD, Ophir Robenpour, MD, Sigal Tal, MD, Yiftah Beer, MD
• Location: Learning Center, East Level 3
• Session Title: MKEE. Musculoskeletal Imaging Education Exhibits
• Session Start: November 30, 7:30 am CT
  
  

Cocktail Event (Please contact Nanox team to register)

• Host: Lawrence Tanenbaum, MD (Nanox Advisory Board Member)
• Location: VU Rooftop Bar, 22nd floor of Hilton Garden Inn, McCormick Place
• Day/Time: December 1, 5:30 pm CT
  
  

Nanox representatives will be available throughout RSNA 2025 for product demonstrations, clinical discussions, and partnership opportunities. Schedule a meeting at the following links:

• Nanox sales team at booth #3914
• Sharon Saban, General Manager, Nanox AI Division, at booth #3914

About Nanox

Nanox (NASDAQ: NNOX) is focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and proprietary digital X-ray source.

Nanox's vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI to enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment and maintaining a clinically driven approach. The Nanox ecosystem includes Nanox.ARC – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox.AI LTD – an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic diseases; Nanox.CLOUD – a cloud-based software platform that manages and stores data collected by Nanox devices, and provides users with tools for in-depth imaging analysis; Nanox.MARKETPLACE – a proprietary decentralized marketplace through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts, and a comprehensive teleradiology services platform. By improving early detection and treatment, Nanox aims to enhance better health outcomes 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) announce for RSNA 2025 on November 13, 2025?

Nanox announced it will showcase the FDA 510(k)-cleared Nanox.ARC X, present clinical data, and preview new AI tools at RSNA 2025 in Chicago.

When did Nanox receive FDA 510(k) clearance for Nanox.ARC X and for which indications?

Nanox received FDA 510(k) clearance in April 2025 for musculoskeletal, pulmonary, intra-abdominal and paranasal indications.

Where and how often will Nanox demonstrate Nanox.ARC X at RSNA 2025?

Live demonstrations of Nanox.ARC X will run every 30 minutes at Booth #3914 (South Hall Level 3) during RSNA 2025 (Nov 30–Dec 4, 2025).

What AI developments did Nanox announce for Nanox.ARC X at RSNA 2025?

The company said it is developing a pulmonary nodule AI for future Nanox.ARC X integration and two standalone AI tools for aortic valve calcification and body composition.

When is the Nanox Innovation Theater presentation at RSNA and who is presenting?

The Innovation Theater presentation is scheduled for December 2, 2025 at 11:00 am CT, presented by Dr. Orit Wimpfheimer, Nanox chief medical officer.

How can investors or partners arrange meetings with Nanox at RSNA 2025?

Nanox representatives and the sales team will be available at Booth #3914; attendees were asked to schedule meetings via the company’s RSNA contact links.