SS Innovations Submits Response to FDA Request
News related to:SS Innovations International, Inc. (the "Company" or "SS Innovations") · 4 min read
FORT LAUDERDALE, Fla., Oct. 13, 2026 /CourierPR/ -- SS Innovations International, Inc. (the "Company" or "SS Innovations"), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that on October 5, 2026, the Company submitted its response to a request for additional information letter (the "AINN") received from the United States Food and Drug Administration (the "FDA") with regard to the Company’s 510(k) submission for its SSi Mantra surgical robotic system (the "SSi Mantra").
The submission included final data from an expanded human clinical and human factors validation study (the "Study") for the SSi Mantra, which was designed to provide essential evidence that the SSi Mantra meets the FDA's requirements for safety, efficacy, and feasibility. The Company also included final data from a bridging study (the "Bridging Study") that it completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga, Colombia.
The Company anticipates that the FDA will complete its review of the Company’s AINN response and the Company’s 510(k) submission for the SSi Mantra in the first quarter of 2027. The Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the Study, the Bridging Study, and the 510(k) submission, which covers the initial indication of cholecystectomy (gallbladder removal).
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.
SS Innovations International, Inc. (Nasdaq: SSII), a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, 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.
The FDA’s request for additional information (the "AINN") is a critical step in the regulatory process for the SSi Mantra. The Company's response to the AINN includes final data from the expanded human clinical and human factors validation study (the "Study") for the SSi Mantra, which was designed to provide essential evidence that the SSi Mantra meets the FDA's requirements for safety, efficacy, and feasibility. The Company also included final data from a bridging study (the "Bridging Study") that it completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga, Colombia.
The FDA is expected to complete its review of the Company’s AINN response and the Company’s 510(k) submission for the SSi Mantra in the first quarter of 2027. The Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the Study, the Bridging Study, and the 510(k) submission, which covers the initial indication of cholecystectomy (gallbladder removal).
SS Innovations International, Inc. (Nasdaq: SSII) is a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a 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.
The FDA’s request for additional information (the "AINN") is a critical step in the regulatory process for the SSi Mantra. The Company's response to the AINN includes final data from the expanded human clinical and human factors validation study (the "Study") for the SSi Mantra, which was designed to provide essential evidence that the SSi Mantra meets the FDA's requirements for safety, efficacy, and feasibility. The Company also included final data from a bridging study (the "Bridging Study")