SS Innovations International, Inc. (NASDAQ: SSII), a developer of surgical robotic technologies, announced that on Oct. 5, 2026, it submitted its response to a request for additional information from the U.S. Food and Drug Administration (FDA) 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. This development matters because it signals tangible progress toward regulatory clearance in the world’s largest medical device market, where SS Innovations aims to make robotic surgery more affordable and accessible.
The SSi Mantra system is a modular, multi-arm robotic platform featuring 3 to 5 robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel for patient-related information, a virtual real-time image of the robotic patient-side arm carts, and the ability to superimpose 3D models of diagnostic imaging. An optional tele-surgeon console, the SSi MantrAsana, is a portable, compact alternative to the standard command center that provides equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The system 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.
SS Innovations is headquartered in India but is a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Its product range includes the proprietary SSi Mantra system and the comprehensive suite of SSi Mudra surgical instruments, which support a variety of surgical robotic procedures including cardiac surgery. For more information, visit the company’s website at ssinnovations.com or its LinkedIn page. The latest news and updates relating to SSII are available in the company’s newsroom at https://ibn.fm/SSII. To view the full press release, visit https://ibn.fm/A6dJ8.
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