<p>此项批准使下一阶段的发展得以进行，最终目标是消除在美国的辅助使用。</p>
<p>新批准的功能为放射科医生提供了直接从数字断层扫描生成的 2D 图像，使得从单次扫描中能够获得 3D 和 2D 视图，而不会使患者暴露于额外的辐射中。</p>
<p>以色列佩塔提克瓦 – 2 月 3 日 – NANO-X IMAGING LTD（“Nanox” 或 “公司”）今天宣布，美国食品药品监督管理局（FDA）已批准 TAP2D 的 510(k) 申请，这是一种针对 Nanox.ARC 和 Nanox.ARC X 数字断层扫描系统的新云端图像增强功能。此项批准标志着 Nanox 在其监管战略中的重要一步，旨在将其断层扫描系统定位为主要诊断解决方案，并推动公司对创新医学影像解决方案的更广泛获取的承诺。</p>
<p>新批准的增强功能为放射科医生提供了额外的清晰 2D 视图，该视图是从数字断层扫描生成的。该功能旨在支持评估，同时保持用户的顺畅工作流程。额外的视图会在现有的临床环境中自动提供，而不会增加临床医生或操作员的复杂性。</p>
<p>Nanox.ARC 和 Nanox.ARC X 是 FDA 批准的多源数字断层扫描系统，利用先进的 3D 成像技术提供增强的诊断能力，其成本和辐射剂量低于传统系统。</p>
<p>Nanox.ARC 系统的软件升级和新功能，如 TAP2D，可以在此项及未来的监管批准后，远程添加到 Nanox.ARC 系统中。</p>
<p>“我们很高兴获得 FDA 对 TAP2D 的批准，” Nanox 首席执行官兼代理董事长 Erez Meltzer 表示。“此项批准为我们在美国消除辅助使用的目标提供了重要的监管见解，这将使 Nanox.ARC 能够作为独立的主要成像解决方案，就像在我们的 CE 标记认证下在欧洲所做的那样。我们将继续专注于提供提升患者护理和扩大高质量成像获取的创新。”</p>
<p>Nanox 计划将新批准的增强软件作为其持续推出成像改进的一部分，提供给现有的安装。</p>
<p><strong>关于 Nanox</strong></p>
<p>Nanox（纳斯达克：NNOX）专注于推动全球向预防性医疗保健的转型，通过提供一个集成的端到端医学影像和医疗服务平台。</p>
<p>Nanox 结合了经济实惠的成像硬件、先进的基于 AI 的解决方案、云端软件、远程放射学的访问、健康 IT 解决方案以及一个市场，以实现更早的疾病检测、改善临床效率和更广泛的医疗获取。</p>
<p>Nanox 的愿景是通过提供从扫描到解读及更远的无缝解决方案，扩大医学影像在传统医院环境内外的覆盖范围。通过利用专有的数字 X 射线技术、基于 AI 的分析和以临床为驱动的方法，Nanox 旨在提高常规成像工作流程的效率，支持早期疾病检测，并改善患者结果。</p>
<p>Nanox 生态系统包括 <strong>Nanox.ARC</strong>，一种经济高效、易于使用和可扩展的 3D 多源数字断层扫描成像系统；<strong>Nanox.AI</strong>，一套基于 AI 的算法，增强常规 CT 成像的解读，以识别与慢性疾病相关的早期迹象；<strong>Nanox.CLOUD</strong>，一个用于安全数据管理、存储和高级成像分析的云平台；<strong>Nanox.MARKETPLACE</strong> 和 <strong>USARAD Holdings</strong>，提供远程放射学和心脏病学专家的访问以及全面的远程放射学服务；以及 <strong>Nanox Health IT</strong>，结合深厚的医疗 IT 专业知识与领先技术合作伙伴，提供 RIS、PACS、AI、口述和安全基础设施解决方案，以简化工作流程并支持更安全、更高效的护理交付。</p>
<p>通过整合成像技术、AI、云基础设施、临床专业知识、市场和健康信息技术，Nanox 旨在降低采用障碍，提高利用率，并推动全球预防性护理的发展。有关更多信息，请访问 www.nanox.vision。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿可能包含前瞻性声明，这些声明受到风险和不确定性的影响。本新闻稿中所有非历史事实的声明均为前瞻性声明。这些声明包括但不限于与公司在其 X 射线源技术和 Nanox.ARC 方面的研究与开发、制造和商业化活动的启动、时间、进展和结果相关的任何声明，以及实现其近期收购的预期收益和公司及被收购公司的预期商业前景。在某些情况下，您可以通过诸如 “可以”、“可能”、“相信”、“可能”、“估计”、“继续”、“预期”、“打算”、“应该”、“计划”、“能够”、“期待”、“预测”、“潜在” 或这些术语的否定形式或其他类似表达来识别前瞻性声明。前瞻性声明基于公司在作出这些声明时所掌握的信息或管理层在当时对未来事件的善意信念，并且受到风险和不确定性的影响，这可能导致实际表现或结果与前瞻性声明中表达或暗示的内容有实质性差异。可能导致实际结果与当前预期有实质性差异的因素包括：(i) Nanox 完成 Nanox 系统开发的能力；(ii) Nanox 成功展示其技术在商业应用中可行性的能力；(iii) Nanox 对其技术、Nanox.ARC 和 Nanox.CLOUD 在全球监管机构获得和维持监管许可或批准的必要性、申请时间的预期，以及与适用质量标准和监管要求的持续合规性的预期；(iv) Nanox 实现收购预期收益的能力，这可能受到竞争、品牌认知度、被收购公司盈利增长和保留关键员工能力等因素的影响；(v) Nanox 与第三方制造商和供应商达成并维持商业合理安排以制造 Nanox.ARC 的能力；(vi) Nanox 系统及其拟议的按扫描付费商业模式的市场接受度；(vii) Nanox 对与第三方合作及其潜在收益的预期；(viii) Nanox 在全球范围内开展业务的能力；(ix) 全球、政治、经济、商业、竞争、市场和监管力量的变化；(x) 与以色列和哈马斯之间当前战争相关的风险以及以色列局势的任何恶化；(xi) 与 COVID-19 大流行或类似公共卫生危机导致的业务中断相关的风险；以及 (xii) 与我们交易相关的潜在诉讼。</p>
<p>有关其他风险和不确定性以及其他重要因素的讨论，任何这些因素都可能导致 Nanox 的实际结果与前瞻性声明中包含的结果不同，请参见 Nanox 截至 2024 年 12 月 31 日的年度报告中标题为 “风险因素” 的部分，以及随后向美国证券交易委员会提交的文件。读者不应对本新闻稿中包含的任何前瞻性声明过于依赖。除法律要求外，Nanox 没有义务在本新闻稿日期之后公开更新任何前瞻性声明，以使这些声明与实际结果或公司预期的变化相符。</p>
<p><strong>联系方式</strong></p>
<p><strong>媒体联系人：</strong></p>
<p>Ben Shannon</p>
<p>ICR Healthcare</p>
<p>NanoxPR@icrinc.com</p>
<p><strong>投资者联系人：</strong></p>
<p>Mike Cavanaugh</p>
<p>ICR Healthcare</p>
<p>mike.cavanaugh@icrhealthcare.com</p>
<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9TVRBd01URTJNamMyTXlNME1ESXpNalk0TlRrak56QXdNREkyTnpZMw?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9TVRBd01URTJNamMyTXlNME1ESXpNalk0TlRrak56QXdNREkyTnpZMw"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml-eu.globenewswire.com/media/MGZmNDY3ZTItMzg2Zi00ZDlkLWE4NjktZjczOTc3MmY4NjNkLTcwMDAyNjc2Ny0yMDI2LTAyLTAzLWVu/tiny/NANO-X-IMAGING-LTD.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml-eu.globenewswire.com/media/MGZmNDY3ZTItMzg2Zi00ZDlkLWE4NjktZjczOTc3MmY4NjNkLTcwMDAyNjc2Ny0yMDI2LTAyLTAzLWVu/tiny/NANO-X-IMAGING-LTD.png"/></p>

标普健康医疗设备 ETF - SPDR

NNOX

美国医药设备 ETF - iShares

<p>Nanox Imaging Ltd 已获得 FDA 510(k) 认证，允许其 Nanox.ARC 和 Nanox.ARC X 系统使用 TAP2D 图像增强功能。此新功能使放射科医生能够从断层合成扫描生成 2D 图像，提供 3D 和 2D 视图而无需额外的辐射暴露。该认证是 Nanox 将其系统定位为美国主要诊断工具战略中的重要一步。该公司旨在提升患者护理并扩大全球医疗影像解决方案的可及性</p>

<p><em>This clearance__enables__the next phase of development aimed__ultimately__at removing the adjunct__use__in the US</em></p>
<div class="lb-trans"><p>此项批准使下一阶段的发展得以进行，最终目标是消除在美国的辅助使用。</p>
</div><p><em>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</em></p>
<div class="lb-trans"><p>新批准的功能为放射科医生提供了直接从数字断层扫描生成的 2D 图像，使得从单次扫描中能够获得 3D 和 2D 视图，而不会使患者暴露于额外的辐射中。</p>
</div><p>PETACH TIKVA, Israel – February3 – 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 increasedaccess to innovative medical imaging solutions.</p>
<div class="lb-trans"><p>以色列佩塔提克瓦 – 2 月 3 日 – NANO-X IMAGING LTD（“Nanox” 或 “公司”）今天宣布，美国食品药品监督管理局（FDA）已批准 TAP2D 的 510(k) 申请，这是一种针对 Nanox.ARC 和 Nanox.ARC X 数字断层扫描系统的新云端图像增强功能。此项批准标志着 Nanox 在其监管战略中的重要一步，旨在将其断层扫描系统定位为主要诊断解决方案，并推动公司对创新医学影像解决方案的更广泛获取的承诺。</p>
</div><p>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.</p>
<div class="lb-trans"><p>新批准的增强功能为放射科医生提供了额外的清晰 2D 视图，该视图是从数字断层扫描生成的。该功能旨在支持评估，同时保持用户的顺畅工作流程。额外的视图会在现有的临床环境中自动提供，而不会增加临床医生或操作员的复杂性。</p>
</div><p>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.</p>
<div class="lb-trans"><p>Nanox.ARC 和 Nanox.ARC X 是 FDA 批准的多源数字断层扫描系统，利用先进的 3D 成像技术提供增强的诊断能力，其成本和辐射剂量低于传统系统。</p>
</div><p>The Nanox.ARC systems’ software upgrades and new capabilities,such as TAP2D,can be added remotely to the Nanox.ARCsystems,following this and future regulatory clearances.</p>
<div class="lb-trans"><p>Nanox.ARC 系统的软件升级和新功能，如 TAP2D，可以在此项及未来的监管批准后，远程添加到 Nanox.ARC 系统中。</p>
</div><p>“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 solutionas 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.”</p>
<div class="lb-trans"><p>“我们很高兴获得 FDA 对 TAP2D 的批准，” Nanox 首席执行官兼代理董事长 Erez Meltzer 表示。“此项批准为我们在美国消除辅助使用的目标提供了重要的监管见解，这将使 Nanox.ARC 能够作为独立的主要成像解决方案，就像在我们的 CE 标记认证下在欧洲所做的那样。我们将继续专注于提供提升患者护理和扩大高质量成像获取的创新。”</p>
</div><p>Nanox plans to make the newly cleared enhancement softwareavailable to existing installations as part of its ongoing rollout of imaging improvements.</p>
<div class="lb-trans"><p>Nanox 计划将新批准的增强软件作为其持续推出成像改进的一部分，提供给现有的安装。</p>
</div><p><strong>About Nanox</strong></p>
<div class="lb-trans"><p><strong>关于 Nanox</strong></p>
</div><p>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.</p>
<div class="lb-trans"><p>Nanox（纳斯达克：NNOX）专注于推动全球向预防性医疗保健的转型，通过提供一个集成的端到端医学影像和医疗服务平台。</p>
</div><p>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.</p>
<div class="lb-trans"><p>Nanox 结合了经济实惠的成像硬件、先进的基于 AI 的解决方案、云端软件、远程放射学的访问、健康 IT 解决方案以及一个市场，以实现更早的疾病检测、改善临床效率和更广泛的医疗获取。</p>
</div><p>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.</p>
<div class="lb-trans"><p>Nanox 的愿景是通过提供从扫描到解读及更远的无缝解决方案，扩大医学影像在传统医院环境内外的覆盖范围。通过利用专有的数字 X 射线技术、基于 AI 的分析和以临床为驱动的方法，Nanox 旨在提高常规成像工作流程的效率，支持早期疾病检测，并改善患者结果。</p>
</div><p>The Nanox ecosystem includes <strong>Nanox.ARC</strong>, a cost-effective, 3D multi-source digital tomosynthesis imaging system designed for ease of use and scalability; <strong>Nanox.AI</strong>, a suite of AI-based algorithms that augment the interpretation of routine CT imaging to identify early signs often associated with chronic disease; <strong>Nanox.CLOUD</strong>, a cloud-based platform for secure data management, storage, and advanced imaginganalytics; <strong>Nanox.MARKETPLACE</strong> and <strong>USARAD Holdings</strong>, which provide access to remote radiology and cardiology experts and comprehensive teleradiology services; and<strong>Nanox Health IT</strong>, 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.</p>
<div class="lb-trans"><p>Nanox 生态系统包括 <strong>Nanox.ARC</strong>，一种经济高效、易于使用和可扩展的 3D 多源数字断层扫描成像系统；<strong>Nanox.AI</strong>，一套基于 AI 的算法，增强常规 CT 成像的解读，以识别与慢性疾病相关的早期迹象；<strong>Nanox.CLOUD</strong>，一个用于安全数据管理、存储和高级成像分析的云平台；<strong>Nanox.MARKETPLACE</strong> 和 <strong>USARAD Holdings</strong>，提供远程放射学和心脏病学专家的访问以及全面的远程放射学服务；以及 <strong>Nanox Health IT</strong>，结合深厚的医疗 IT 专业知识与领先技术合作伙伴，提供 RIS、PACS、AI、口述和安全基础设施解决方案，以简化工作流程并支持更安全、更高效的护理交付。</p>
</div><p>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</p>
<div class="lb-trans"><p>通过整合成像技术、AI、云基础设施、临床专业知识、市场和健康信息技术，Nanox 旨在降低采用障碍，提高利用率，并推动全球预防性护理的发展。有关更多信息，请访问 www.nanox.vision。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>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.</p>
<div class="lb-trans"><p>本新闻稿可能包含前瞻性声明，这些声明受到风险和不确定性的影响。本新闻稿中所有非历史事实的声明均为前瞻性声明。这些声明包括但不限于与公司在其 X 射线源技术和 Nanox.ARC 方面的研究与开发、制造和商业化活动的启动、时间、进展和结果相关的任何声明，以及实现其近期收购的预期收益和公司及被收购公司的预期商业前景。在某些情况下，您可以通过诸如 “可以”、“可能”、“相信”、“可能”、“估计”、“继续”、“预期”、“打算”、“应该”、“计划”、“能够”、“期待”、“预测”、“潜在” 或这些术语的否定形式或其他类似表达来识别前瞻性声明。前瞻性声明基于公司在作出这些声明时所掌握的信息或管理层在当时对未来事件的善意信念，并且受到风险和不确定性的影响，这可能导致实际表现或结果与前瞻性声明中表达或暗示的内容有实质性差异。可能导致实际结果与当前预期有实质性差异的因素包括：(i) Nanox 完成 Nanox 系统开发的能力；(ii) Nanox 成功展示其技术在商业应用中可行性的能力；(iii) Nanox 对其技术、Nanox.ARC 和 Nanox.CLOUD 在全球监管机构获得和维持监管许可或批准的必要性、申请时间的预期，以及与适用质量标准和监管要求的持续合规性的预期；(iv) Nanox 实现收购预期收益的能力，这可能受到竞争、品牌认知度、被收购公司盈利增长和保留关键员工能力等因素的影响；(v) Nanox 与第三方制造商和供应商达成并维持商业合理安排以制造 Nanox.ARC 的能力；(vi) Nanox 系统及其拟议的按扫描付费商业模式的市场接受度；(vii) Nanox 对与第三方合作及其潜在收益的预期；(viii) Nanox 在全球范围内开展业务的能力；(ix) 全球、政治、经济、商业、竞争、市场和监管力量的变化；(x) 与以色列和哈马斯之间当前战争相关的风险以及以色列局势的任何恶化；(xi) 与 COVID-19 大流行或类似公共卫生危机导致的业务中断相关的风险；以及 (xii) 与我们交易相关的潜在诉讼。</p>
</div><p>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.</p>
<div class="lb-trans"><p>有关其他风险和不确定性以及其他重要因素的讨论，任何这些因素都可能导致 Nanox 的实际结果与前瞻性声明中包含的结果不同，请参见 Nanox 截至 2024 年 12 月 31 日的年度报告中标题为 “风险因素” 的部分，以及随后向美国证券交易委员会提交的文件。读者不应对本新闻稿中包含的任何前瞻性声明过于依赖。除法律要求外，Nanox 没有义务在本新闻稿日期之后公开更新任何前瞻性声明，以使这些声明与实际结果或公司预期的变化相符。</p>
</div><p><strong>Contacts</strong></p>
<div class="lb-trans"><p><strong>联系方式</strong></p>
</div><p><strong>Media Contact:</strong></p>
<div class="lb-trans"><p><strong>媒体联系人：</strong></p>
</div><p>Ben Shannon</p>
<div class="lb-trans"><p>Ben Shannon</p>
</div><p>ICR Healthcare</p>
<div class="lb-trans"><p>ICR Healthcare</p>
</div><p>NanoxPR@icrinc.com</p>
<div class="lb-trans"><p>NanoxPR@icrinc.com</p>
</div><p><strong>Investor Contact</strong>:</p>
<div class="lb-trans"><p><strong>投资者联系人：</strong></p>
</div><p>Mike Cavanaugh</p>
<div class="lb-trans"><p>Mike Cavanaugh</p>
</div><p>ICR Healthcare</p>
<div class="lb-trans"><p>ICR Healthcare</p>
</div><p>mike.cavanaugh@icrhealthcare.com</p>
<div class="lb-trans"><p>mike.cavanaugh@icrhealthcare.com</p>
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