Hugo RAS system brings choice to the U.S., coupled with the full suite of Medtronic surgical offerings, ultimately creating a connected and integrated operating room today and into the future.

Hugo RAS系统为美国带来了选择，结合了美敦力全套外科手术产品，最终打造了连接和集成的手术室，惠及当下与未来。

GALWAY,

戈尔韦，

Ireland

爱尔兰

,

，

Dec. 3, 2025

2025年12月3日

/

/

PRNewswire

美通社

/ -- Medtronic (NYSE: MDT), a global leader in surgical innovation, today announced the U.S. Food and Drug Administration (FDA) has cleared the Hugo™ robotic-assisted surgery (RAS) system for use in urologic surgical procedures. The Hugo RAS system's clearance brings a versatile robotic-assisted platform to U.S.

/ -- 全球外科创新领域的领导者美敦力（纽约证券交易所代码：MDT）今天宣布，美国食品药品监督管理局 (FDA) 已批准 Hugo™ 机器人辅助手术 (RAS) 系统用于泌尿外科手术。Hugo RAS 系统的获批为美国带来了一个多功能的机器人辅助平台。

surgeons and health systems seeking to expand soft-tissue robotic surgery programs and access to minimally invasive care..

寻求扩展软组织机器人手术项目和微创治疗机会的外科医生和卫生系统。

The U.S. leads the world in robotic surgery adoption, yet hospitals continue to face challenges in capacity and access. The introduction of the Hugo RAS system in the U.S. helps address this gap, offering an innovative approach to robotic-assisted surgery from the global leader in surgery and bringing choice to hospitals and surgeons across the country..

美国在机器人手术的应用上处于世界领先地位，但医院在容量和获取途径方面仍面临挑战。Hugo RAS系统的引入有助于弥补这一差距，为机器人辅助手术提供了创新方法，该系统由全球外科领域的领导者推出，为美国各地的医院和外科医生带来了更多选择。

'This is an incredibly exciting day for healthcare in

“这是医疗保健领域令人难以置信的激动人心的一天，

the United States

美国

. FDA clearance of the Hugo RAS system means there is now choice for hospitals looking to expand their robotic programs and increases access for patients,' said

FDA对Hugo RAS系统的批准意味着现在那些希望扩展其机器人项目的医院有了更多选择，并且增加了患者的使用机会。

Rajit Kamal

拉吉特·卡马尔

, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. 'As we begin our purposeful launch of the Hugo RAS system in the U.S., our focus is on building a strong foundation with leading hospitals through our differentiated approach to partnership, rooted in our enduring commitment to provide an excellent customer experience and enable surgical teams to deliver the best possible outcomes for their patients.'.

，美敦力外科业务机器人手术技术部门的副总裁兼总经理。“随着我们开始在美国有目的地推出Hugo RAS系统，我们的重点是通过我们独特的合作伙伴关系方法，与领先的医院建立坚实的基础，这种方法植根于我们对提供卓越客户体验的持久承诺，并使外科团队能够为患者提供最佳的治疗结果。”

Thoughtfully designed with input from surgeons and hospital administrators to shape the future of surgery, the Hugo RAS system includes three main differentiators:

Hugo RAS 系统经过深思熟虑的设计，结合了外科医生和医院管理人员的意见，以塑造手术的未来，该系统包括三个主要区别点：

Modular Design

模块化设计

: The Hugo RAS system's innovative modular design means the robotic arms can be easily moved, shared, and deployed across any care setting — helping to maximize utilization and providing surgeons flexibility to customize their approach to optimize anatomical access for each patient's unique needs. The open design of the surgeon console provides greater situational awareness and visualization, reduces physical strain, and creates enhanced training opportunities for surgical teams — enabling better bedside communication and team integration..

：Hugo RAS系统的创新模块化设计意味着机械臂可以轻松移动、共享并部署于任何护理环境中，有助于最大化设备利用率，同时为外科医生提供灵活性，根据每位患者的不同需求定制方案以优化解剖学操作路径。外科医生控制台的开放式设计提供了更出色的情境感知和可视化能力，减轻了身体负担，并为手术团队创造了更好的培训机会，实现了更佳的床旁沟通和团队协作。

Digital Ecosystem

数字生态系统

: The Hugo RAS system connects seamlessly with the Touch Surgery™ ecosystem, which provides pre-operative training tools, remote tele-proctoring capabilities, and AI-powered post-operative case insights.

：Hugo RAS 系统与 Touch Surgery™ 生态系统无缝连接，该系统提供术前培训工具、远程指导能力以及由人工智能驱动的术后案例分析。

†

†

Surgeons may securely access case videos minutes after a procedure is completed, supporting continuous improvement and collaboration among hospital teams and with their peers in the global surgical community.

手术医生可以在手术完成数分钟后安全地访问病例视频，从而支持医院团队之间以及与全球外科界同行的持续改进和协作。

Differentiated Partnership

差异化合作

: Medtronic is the first and only company that can meet surgeon needs across all surgical modalities — open, laparoscopic, and robotic-assisted. The addition of the Hugo RAS system provides surgical teams access to world-class robotic training, deep clinical and technical expertise, and choice when determining the best surgical approach for each patient's unique needs, with the opportunity to use trusted Medtronic technologies and instruments as technology advances. .

美敦力是第一家也是唯一一家能够满足外科医生在所有手术方式（开放手术、腹腔镜手术和机器人辅助手术）需求的公司。Hugo RAS系统的加入为手术团队提供了世界级的机器人培训、深厚的临床和技术专业知识，以及在确定每位患者独特需求的最佳手术方案时的选择权，并有机会随着技术的进步使用值得信赖的美敦力技术和仪器。

'The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery,' said Dr.

“Hugo RAS 系统代表了一种全新且令人兴奋的机器人辅助手术方法，”博士说道。

James Porter

詹姆斯·波特

, a urologic surgeon and chief medical officer for Robotic Surgical Technologies and Digital Technologies within the Surgical business at Medtronic. 'We're excited for surgical teams in the U.S. to experience the differentiated technology and partnership from Medtronic, which supports them at every stage of their robotic surgical journey.'.

，泌尿外科医生，美敦力外科业务部门机器人手术技术和数字技术的首席医疗官。“我们很高兴美国的手术团队能够体验到美敦力独特的技术和合作关系，这将支持他们在机器人手术过程中的每一个阶段。”

With FDA clearance, the Hugo RAS system is indicated for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy — common procedures that account for about 230,000 surgeries per year in the U.S.

获得FDA批准后，Hugo RAS系统可用于包括前列腺切除术、肾切除术和膀胱切除术在内的微创泌尿外科手术——这些常见手术在美国每年约有23万台。

The Expand URO investigational device exemption clinical study —

扩张URO研究设备豁免临床研究——

the largest ever completed for multi-port robotic-assisted urological surgery in the U.S.

美国完成的多端口机器人辅助泌尿外科手术中规模最大的一次。

— demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints in urologic surgical procedures, with outcomes that are consistent with published literature.

— 证明了Hugo RAS系统在泌尿外科手术中达到了主要的安全性和有效性终点，其结果与已发表的文献一致。

Outside the U.S., the Hugo RAS system has been used in tens of thousands of urologic, gynecologic, and general surgery procedures in more than 30 countries across 5 continents. Medtronic intends to expand the Hugo RAS system's use in the U.S. to additional surgical specialties over time, with indications for general and gynecologic surgical procedures expected to follow the initial urology clearance..

在美国以外，Hugo RAS系统已在五大洲30多个国家的数万例泌尿外科、妇科和普通外科手术中使用。美敦力计划逐步扩大Hugo RAS系统在美国的应用范围至其他外科专业，预计在最初的泌尿外科许可之后，还将涵盖普通外科和妇科手术的适应症。

The introduction of the Hugo RAS system in the U.S. builds on Medtronic's broad surgical offering, including the Touch Surgery ecosystem, to deliver a connected, integrated operating room — today and in the future.

在美国推出的Hugo RAS系统基于美敦力广泛的手术产品组合，包括Touch Surgery生态系统，旨在实现当下和未来的连接性、集成化手术室。

For more information, visit

更多信息，请访问

medtronic.com/hugoishere

medtronic.com/hugoishere

.

。

†The Medtronic Touch Surgery™ ecosystem is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition. Performance Insights are available for select procedures, instruments, and anatomy.

†Medtronic Touch Surgery™ 生态系统并非用于指导手术，或协助诊断或治疗疾病或病症。性能洞察适用于特定的手术、器械和解剖结构。

About Medtronic

关于美敦力

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,

大胆思考。更大胆的行动。我们是美敦力。美敦力公司，总部位于戈尔韦，

Ireland

爱尔兰

, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries.

是全球领先的医疗技术公司，大胆攻克人类面临的最棘手健康问题，寻找并提供解决方案。我们的使命——减轻病痛、恢复健康、延长生命——团结了遍布150多个国家的95,000多名充满热情的员工。

Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day.

我们的技术和疗法治疗70种健康状况，包括心脏设备、手术机器人、胰岛素泵、手术工具、患者监测系统等。凭借我们多样化的知识、永无止境的好奇心和帮助所有需要帮助的人的愿望，我们提供了创新的技术，每秒、每小时、每一天都在改变两个人的生活。

Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit .

随着我们赋能以洞察力为导向的护理、以人为本的体验以及为我们的世界带来更好的结果，期待我们做得更多。在我们所做的每一件事中，我们都在创造非凡。欲了解有关美敦力公司的更多信息，请访问。

www.Medtronic.com

www.美敦力.com

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。

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

任何前瞻性陈述均受风险和不确定性的影响，如美敦力向证券交易委员会提交的定期报告中所述。实际结果可能与预期结果有重大差异。

Contacts:

联系人：

Gary Jeanfaivre

加里·让福伊尔

Public Relations

公共关系

+1-203-556-0777

+1-203-556-0777

Ryan Weispfenning

瑞安·魏斯芬宁

Investor Relations

投资者关系

+1-612-839-4549

+1-612-839-4549

SOURCE Medtronic plc

来源：美敦力公司