SS创新公司向FDA提交了公司SSi Mantra手术机器人系统的510(k)上市前通知-动脉网

SS Innovations Submits 510(k) Premarket Notification to the FDA for the Company’s SSi Mantra Surgical Robotic System

AHHM 等信源发布 2025-12-09 14:26

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SS Innovations International, Inc. a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company submitted a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) on December 5, 2025, for the SSi Mantra surgical robotic system for multiple specialty procedure types, including: general, urological, colorectal, gynecological, and cardiac surgery..

SS创新国际公司（SS Innovations International, Inc.）是一家致力于开发创新外科机器人技术的公司，旨在使机器人手术变得经济实惠并惠及全球人口。该公司今天宣布，已于2025年12月5日向美国食品药品监督管理局（“FDA”）提交了SSi Mantra外科机器人系统的510(k)上市前通知，该系统适用于多种专科手术类型，包括：普通外科、泌尿外科、结直肠外科、妇科和心脏外科手术。

Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Our submission of a 510(k) premarket notification to the FDA marks an important milestone in our strategic plan to introduce the Company’s advanced, cost-efficient SSi Mantra surgical robotic system to the U.S.

SS创新公司的董事长兼首席执行官苏迪尔·斯里瓦斯塔瓦博士评论道：“我们向FDA提交510(k)上市前通知标志着我们在将公司先进的、具有成本效益的SSi Mantra手术机器人系统引入美国市场的战略计划中迈出了重要一步。”

market. Given its affordability, differentiated technology, and proven performance across our existing global installations, we believe the SSi Mantra represents a highly compelling option for hospitals and surgeons in the United States, especially those serving underserved patient communities.”.

市场。鉴于其经济实惠、差异化技术以及在我们现有的全球安装中的卓越表现，我们相信SSi Mantra对于美国的医院和外科医生来说是一个非常有吸引力的选择，特别是那些服务于服务不足的患者群体的医院和医生。”

Based on a pre-submission meeting and subsequent discussions with the FDA, the Company decided to pursue a 510(k) submission, rather than a De Novo request for the SSi Mantra surgical robotic system, aiming to benefit from the pathway’s potential speed and cost efficiencies.

基于与 FDA 召开的提交前会议及后续讨论，公司决定为 SSi Mantra 外科手术机器人系统进行 510(k) 提交，而非 De Novo 申请，旨在利用该途径潜在的速度和成本效益。

The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and a submitter's response time.

FDA 表示，其目标是在收到 510(k) 递交后的 90 天内完成审评。但由于受理审评 15 天、提交额外信息以及递交人响应时间等因素，批准时间可能会更长。

Separately, the Company continues along the pathway towards a European Union CE marking certification for the SSi Mantra that it believes it could obtain in the first half of 2026.

公司还在继续沿着通往欧盟CE标志认证的道路前进，预计可能在2026年上半年获得该认证。

As of November 30, 2025, the SSi Mantra cumulative installed base totaled 138 systems across eight countries where the Company’s surgical robotic system has received regulatory approval. To date, 137 hospitals have installed the SSi Mantra and over 7,300 surgical procedures have been performed, including 88 telesurgeries and 390 cardiac procedures. .

截至2025年11月30日，SSi Mantra累计安装基础总数达到138套系统，分布在公司外科机器人系统已获得监管批准的八个国家。迄今为止，已有137家医院安装了SSi Mantra，完成了超过7,300例手术，其中包括88例远程手术和390例心脏手术。

About SS Innovations

关于SS创新公司

SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery.

SS创新国际公司（纳斯达克股票代码：SSII）致力于开发创新的外科机器人技术，旨在使机器人手术的优势能够以可负担和可及的方式惠及全球更广泛的人群。公司产品系列包括其专有的“SSi Mantra”外科机器人系统及其全面的“SSi Mudra”外科手术器械套件，这些产品支持多种外科手术，包括机器人心脏手术。

An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates..

总部位于印度的美国公司 SS Innovations 计划扩大其技术先进、用户友好且经济实惠的外科手术机器人解决方案的全球影响力。如需更多信息和更新，请访问公司网站 ssinnovations.com 或 LinkedIn。

About the SSi Mantra

关于SSi箴言

The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging.

SSi Mantra外科手术机器人系统是一个用户友好、模块化、多臂的系统，拥有许多先进技术特性，包括：3到5个模块化的机械臂、一个开放式符合人体工程学的主刀医生控制中心、一个大型3D 4K显示器、一个用于显示所有患者相关信息的触摸屏监视器、机械臂推车的虚拟实时图像，以及能够叠加诊断影像的3D模型的功能。

A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures..

视觉推车为床旁团队提供与外科医生相同的放大3D 4K视图，以提高安全性和效率。SSi Mantra利用超过40种不同类型的机器人内窥镜手术器械，支持包括心脏外科在内的不同专科。SSi Mantra已在印度经过100多种不同类型手术的临床验证。

Forward Looking Statements

前瞻性声明

This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements.

本新闻稿可能包含并非历史事实的陈述，这些陈述依据1995年《私人证券诉讼改革法案》被视为前瞻性陈述。诸如“预期”、“假设”、“相信”、“估计”、“预计”、“将”、“意图”、“可能”、“计划”、“预计”、“应该”、“可以”、“寻求”、“设计”、“潜力”、“预测”、“目标”、“目的”、“指标”等词汇或这些词汇的否定形式或其他类似表达，用于识别此类前瞻性陈述。

These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements..

这些声明涉及未来事件或 SS Innovations 未来的财务表现，包含已知和未知的风险、不确定性以及其他可能导致我们的实际结果、活动水平、表现或成就与这些前瞻性声明中明示或暗示的任何未来结果、活动水平、表现或成就存在重大差异的因素。

Investor Contact:

投资者联系人：

The Equity Group

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Devin Sullivan, Managing Director