NANO-X IMAGING LTD an innovative medical imaging technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Nanox.ARC X, its new multi-source digital tomosynthesis system. The FDA 510(k) clearance was received in less than 30 days from the date of submission and covers the production of tomographic images for general use, including the human musculoskeletal system and pulmonary, intra-abdominal and paranasal sinus indications, adjunctive to conventional radiography on adult patients..

纳米-X成像有限公司，一家创新的医疗成像技术公司，今日宣布其新型多源数字体层合成系统Nanox.ARC X已获得美国食品药品监督管理局（FDA）的510(k)许可。FDA的510(k)许可在提交申请后不到30天内获批，涵盖用于通用的断层图像生成，包括人体肌肉骨骼系统、肺部、腹腔内及副鼻窦适应症，并作为成人患者常规X射线摄影的辅助手段。

The Nanox.ARC X maintains the Nanox.ARC’s proprietary digital Nanox.SOURCE and advanced tomosynthesis technology with a cold cathode, which enables it to create a more comprehensive, sliced three-dimensional view of the body, enhance visualization with multiple layers of images, and reduce the super-imposition of structures often seen in 2D X-rays.

Nanox.ARC X 保留了 Nanox.ARC 独有的数字 Nanox.SOURCE 和先进的冷阴极断层合成技术，能够生成更全面的、分层的三维人体视图，通过多层图像增强可视化效果，并减少在二维 X 光中常见的结构重叠问题。

The Nanox.ARC X introduces a fully integrated, single-unit system with a streamlined design that significantly reduces the physical footprint. The system features 'plug and play' one-day installation capability, making advanced tomosynthesis technology more accessible to diverse healthcare settings with space constraints..

Nanox.ARC X 引入了一套完全集成的单一单元系统，其流线型设计大幅减少了物理空间占用。该系统具备“即插即用”的一天安装能力，使先进的断层合成技术更容易进入空间有限的各类医疗环境。

“The FDA clearance of the Nanox.ARC X marks an important evolution in our imaging technology,” said Erez Meltzer, Chief Executive Officer and Acting Chairman of Nanox. “By integrating our proprietary digital technology in this new imaging system, we’re making it easier for healthcare providers to adopt digital 3D imaging.

“Nanox.ARC X 获得 FDA 批准标志着我们的成像技术迈出了重要的一步，” Nanox 首席执行官兼代理主席 Erez Meltzer 表示。“通过将我们专有的数字技术整合到这个新的成像系统中，我们让医疗机构更轻松地采用数字 3D 成像。”

This milestone advances our mission to expand access to essential medical imaging technology to more patients, regardless of their location. We look forward to introducing further capabilities to the Nanox.ARC X in the future and making them available through remote and immediate upgrades.”.

这一里程碑推动了我们的使命，即不论患者身在何处，都要扩大他们获得必要医学影像技术的机会。我们期待未来为Nanox.ARC X引入更多功能，并通过远程和即时升级使它们可用。

The Nanox.ARC X is designed to be installed in any standard X-ray shielded room with minimal infrastructure requirements. The system operates on standard power (110v/230v 16A) and features a cables-free design for enhanced user and patient safety, ease of cleaning, and maintenance.

Nanox.ARC X 旨在安装于任何标准的X射线屏蔽室内，对基础设施要求极低。该系统使用标准电源（110v/230v 16A），并采用无电缆设计，以提升用户和患者的安全性，同时便于清洁和维护。

Nanox will offer the Nanox.ARC X system, later this year, alongside the current Nanox.ARC, expanding the Company’s product portfolio to meet diverse customer needs and use cases.

今年晚些时候，Nanox将推出Nanox.ARC X系统，与现有的Nanox.ARC一同提供，以扩展公司产品组合，满足多样化的客户需求和使用场景。

For more information about Nanox's complete suite of medical imaging solutions, please visit www.nanox.vision.

有关Nanox全套医学影像解决方案的更多信息，请访问www.nanox.vision。

About Nanox

关于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（纳斯达克股票代码：NNOX）致力于通过提供基于先进人工智能和专有数字X射线源的经济实惠的医学影像技术全解决方案，推动全球向预防性医疗保健的转型。

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.

Nanox的愿景包括扩大Nanox技术在医院内外的覆盖范围，提供从扫描到诊断的无缝端到端解决方案，利用人工智能提高常规医学影像技术和流程的效率，以改善早期检测和治疗，并保持以临床为导向的方法。

The Nanox ecosystem includes Nanox.ARC and Nanox.ARC X – a multi-source digital tomosynthesis system that is cost-effective and user-friendly; Nanox AI Ltd. – with 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.

Nanox生态系统包括Nanox.ARC和Nanox.ARC X——一种经济高效且用户友好的多源数字体层合成系统；Nanox AI Ltd.——拥有一套基于人工智能的算法，能够增强常规CT影像解读，突出与慢性病相关的早期迹象；Nanox.CLOUD——一个基于云的软件平台，用于管理和存储由Nanox设备收集的数据，并为用户提供深入影像分析的工具；Nanox.MARKETPLACE——通过Nanox子公司USARAD Holdings Inc.运营的一个专有去中心化市场，提供远程访问放射学和心脏病学专家的服务，以及全面的远程放射学服务平台。

By improving early detection and treatment, Nanox aims to enhance better health outcomes worldwide. For more information, please visit www.nanox.vision..

通过改进早期检测和治疗，Nanox旨在改善全球健康状况。欲了解更多信息，请访问 www.nanox.vision。

Forward-Looking Statements

前瞻性声明

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 and/or the Nanox.ARC X, the ability to realize the expected benefits of its recent acquisitions and the projected business prospects of the Company and the acquired companies.

本新闻稿可能包含前瞻性陈述，这些陈述受风险和不确定性的影响。本新闻稿中所有非历史事实的陈述均为前瞻性陈述。此类陈述包括但不限于有关公司关于其X射线源技术及Nanox.ARC和/或Nanox.ARC X的研发、制造和商业活动的启动、时间、进展和结果的任何陈述，实现其近期收购预期效益的能力，以及公司和被收购公司的预计业务前景。

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.

在某些情况下，您可以通过诸如“可以”、“可能”、“相信”、“或许”、“估计”、“继续”、“预期”、“打算”、“应该”、“计划”、“能够”、“预计”、“预测”、“潜在”等术语或这些词语的否定形式或其他类似表述来识别前瞻性陈述。前瞻性陈述基于公司作出这些陈述时所掌握的信息，或管理层在当时对未来的善意信念，且受到可能导致实际表现或结果与前瞻性陈述中表达或暗示的内容存在重大差异的风险和不确定性的影响。

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.

可能导致实际结果与当前预期存在重大差异的因素包括：(i) Nanox完成Nanox系统开发的能力相关的风险；(ii) Nanox成功证明其技术在商业应用中的可行性的能力相关的风险；(iii) Nanox对其技术、Nanox.ARC在监管审批或批准的必要性、申请时间、以及获取和维持方面的预期相关的风险。

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.

有关其他风险和不确定性以及其他重要因素的讨论，这些因素中的任何一项都可能导致Nanox的实际结果与前瞻性声明中包含的结果不同，参见Nanox截至2024年12月31日的年度报告Form 20-F中标题为“风险因素”的部分，以及随后向美国提交的文件。

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..

美国证券交易委员会。读者不应过分依赖本新闻稿中包含的任何前瞻性陈述。除非法律要求，Nanox 没有义务在本新闻稿发布日期之后公开更新任何前瞻性陈述，以使这些陈述符合实际结果或公司预期的变化。

Contacts

联系人

Media Contact

媒体联系人

ICR Healthcare

ICR医疗保健

[email protected]

电子邮件地址

Investor Contact

投资者联系方式

Mike Cavanaugh

迈克·卡瓦诺

ICR Healthcare

ICR医疗保健

[email protected]

电子邮件地址

Source: globenewswire.com

来源：globenewswire.com