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.
The SSi Mantra system is designed to make robotic surgery more affordable and accessible. It features a modular, multi-arm design with 3 to 5 robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and a touch panel monitor for patient information. The system also includes 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, provides portability and telesurgery capability. The system utilizes over 40 different types of robotic endo-surgical instruments, including 5mm instruments for pediatric and ENT surgeries, and a vision cart that provides the table-side team with the same magnified 3D 4K view as the surgeon. The SSi Mantra has been clinically validated in India in more than 190 different types of surgical procedures.
This FDA submission is a critical step for SS Innovations as it seeks to enter the U.S. market, which is the largest market for surgical robotics. The company's vision is to make robotic surgery affordable and accessible to a larger segment of the global population. If approved, the SSi Mantra could provide a cost-effective alternative to existing robotic surgical systems, potentially increasing adoption in hospitals and surgery centers that have been priced out of the market. The news is also significant for investors, as the U.S. market represents a substantial growth opportunity for the company. The company's stock is traded on NASDAQ under the ticker SSII. For more information, visit the company's website at ssinnovations.com or its LinkedIn page. The full press release can be viewed at https://ibn.fm/A6dJ8. The latest news and updates relating to SSII are available in the company's newsroom at https://ibn.fm/SSII.
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