SS Innovations International, Inc. has received regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya, expanding the technology's availability to underserved regions. The approvals position the company to address underpenetrated markets with a system designed to be cost-effective and user-friendly.
The company received approval from Colombia's Instituto Nacional de Vigilancia de Medicamentos y Alimentos in November 2025, Oman's Directorate General of Pharmaceutical Affairs and Drug Control in November 2025, Sri Lanka's National Medicines Regulatory Authority in January 2026, and Kenya's Pharmacy and Poisons Board in January 2026. These approvals add to existing regulatory clearances in eleven countries including India, Ecuador, Guatemala, Indonesia, Philippines, Ukraine, and the United Arab Emirates.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, stated the company continues to expand its global opportunity with an eye on democratizing access to cutting-edge robotic surgery for patients in underserved regions. The company is committed to decentralizing excellence in surgical robotic care in these new jurisdictions while pursuing established United States and European Union markets.
The SSi Mantra system features 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and the ability for superimposition of 3D models of diagnostic imaging. The optional SSi MantrAsana Tele Surgeon Console provides equivalent control functionality while enabling enhanced portability and telesurgery capability. The system utilizes over 40 different types of robotic endo-surgical instruments to support different specialties including cardiac surgery, with 5mm instruments available for pediatric and ENT surgeries.
As of December 31, 2025, the SSi Mantra cumulative installed base totaled 168 across ten countries, with cumulative surgeries reaching 7,885 including 390 cardiac procedures and 121 pediatric surgeries. More than 150 telesurgeries have been performed with the system to date. The system has been clinically validated in India in more than 100 different types of surgical procedures.
The company anticipates that the U.S. Food and Drug Administration will complete its review of the 510(k) premarket notification for the SSi Mantra by mid-2026. Separately, SS Innovations continues along the pathway toward European Union CE marking certification, which the company believes it can obtain in 2026. For more information, visit the company's website at https://ssinnovations.com.
This expansion matters because it represents a significant step toward making advanced surgical robotics accessible in regions where cost has traditionally been a barrier. The approvals in Colombia, Oman, Sri Lanka, and Kenya could potentially improve surgical outcomes and increase procedural availability for millions of patients who previously lacked access to robotic-assisted surgery. The system's cost advantages combined with its advanced technology could disrupt traditional market dynamics dominated by higher-priced competitors.
The implications extend beyond immediate patient care to include training opportunities for local medical professionals and potential economic benefits through healthcare infrastructure development. As robotic surgery becomes more accessible globally, it could help address healthcare disparities between developed and developing nations. The company's progress toward U.S. and European approvals suggests a broader strategy to compete in both emerging and established markets simultaneously.
