SS Innovations International (NASDAQ: SSII), a developer of surgical robotic technologies, announced that it submitted its response to a request for additional information from the U.S. Food and Drug Administration (FDA) on Oct. 5, 2026, regarding its 510(k) submission for the SSi Mantra surgical robotic system. The response includes final data from an expanded human clinical and human factors validation study, as well as a bridging study completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network. The submission covers the initial indication of cholecystectomy, or gallbladder removal. The company anticipates that the FDA will complete its review of the response and 510(k) submission in the first quarter of 2027, advancing its efforts to introduce the SSi Mantra system to the U.S. market.
To view the full press release, visit https://ibn.fm/A6dJ8
About SS Innovations
SS Innovations International, Inc. 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 robotic procedures including cardiac surgery. Headquartered in India, SS Innovations is a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at or for more information and updates.
At a glance
- Company
- SS Innovations International, Inc.
- Ticker
- NASDAQ: SSII
- Announcement
- Regulatory
- Location
- United States
Key figures
- FDA response submitted
- Oct. 5, 2026
- Bridging study completed
- August 2026
- Expected FDA review completion
- first quarter of 2027
- Instrument types
- over 40
- Procedures in which the system has been clinically validated in India
- more than 190
Products and programs
About the SSi Mantra
The SSi Mantra surgical robotic system is a modular, multi-arm system with 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. The optional SSi MantrAsana tele-surgeon console is a portable, compact alternative to the SSi Mantra’s standard surgeon command center that is intended to provide equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. A vision cart is designed to provide the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra has been clinically validated in India in more than 190 different types of surgical procedures.
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In brief
SS Innovations International says it sent the U.S. Food and Drug Administration its reply to questions about the 510(k) filing for its SSi Mantra surgical robot. The company submitted the response on October 5, 2026, with final results from expanded human clinical and human-factors validation work, plus a bridging study finished in August at Hospital Internacional de Colombia. The filing seeks an initial use indication for gallbladder removal. SS Innovations expects the agency to finish evaluating the response and submission in the first quarter of 2027. The company describes this review as part of its work to bring the system to the U.S. market. The release also outlines the system’s modular design and related surgical instruments.
Key takeaways
- The company submitted its FDA response on October 5, 2026, for the SSi Mantra 510(k) filing.
- The response includes final results from expanded human clinical and human-factors validation work and a bridging study.
- The initial requested use indication is cholecystectomy, or gallbladder removal.
- SS Innovations anticipates FDA review will conclude in the first quarter of 2027.
SEC filings
Earlier from SS Innovations
- SS Innovations International (NASDAQ: SSII) Builds Telerobotic Surgery Position as Remote Procedures Gain Ground
- SS Innovations International (NASDAQ: SSII) Expands Global Footprint as SSi Mantra Procedures Reach 14,103
- SS Innovations International (NASDAQ: SSII) Brings Robotic Cardiac Surgery to Sri Lanka
- SS Innovations International (NASDAQ: SSII) Reports 79% Growth in SSi Mantra Procedures, Expands Global Reach
- SS Innovations International (NASDAQ: SSII) Turning India’s Surgical Robotics Opportunity Into a Global Growth Story
