SS Innovations International, Inc. (Nasdaq: SSII), a developer of surgical robotic technologies, announced today that it has received regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka and Kenya. The approvals, granted by national health authorities in each country, mark a significant expansion of the company's global footprint and advance its mission to make robotic surgery affordable and accessible worldwide.
The Colombian approval came from the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in November 2025, followed by the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) in Oman also in November 2025. Sri Lanka's National Medicines Regulatory Authority (NMRA) approved the system in January 2026, and the Pharmacy and Poisons Board (PPB) in Kenya followed suit in January 2026. These markets are considered underpenetrated for robotic surgery, and SS Innovations believes the SSi Mantra’s cost advantages, advanced technology, and ease of training position it favorably to address the unmet need.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, stated, “We continue to expand SS Innovations’ global opportunity with an eye on democratizing access to cutting-edge robotic surgery for patients in underserved regions of the world. Over the past few months, our advanced, cost-efficient SSi Mantra surgical robotic system has received regulatory approval in Colombia, Oman, Sri Lanka, and Kenya. We are committed to decentralizing excellence in surgical robotic care in these new jurisdictions, among others, while pursuing the established United States and Europe Union markets.” He added that the company anticipates U.S. Food and Drug Administration review of its 510(k) premarket notification to be completed by mid-2026, and that CE marking certification in the European Union is expected in 2026.
With these latest approvals, the SSi Mantra has now received regulatory clearance in eleven countries, including India, Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates. As of December 31, 2025, the SSi Mantra cumulative installed base totaled 168 across ten countries, and cumulative surgeries reached 7,885, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, more than 150 telesurgeries have been performed with the system.
The SSi Mantra is a modular, multi-arm system featuring 3 to 5 robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and a touch panel for patient information. It includes over 40 different types of robotic endo-surgical instruments supporting various specialties, including cardiac surgery, and 5mm instruments for pediatric and ENT procedures. The optional SSi MantrAsana Tele Surgeon Console enables enhanced portability and telesurgery capability. The system has been clinically validated in India in more than 100 different types of surgical procedures. More information is available on the company's website at ssinnovations.com.
