SS Innovations International, Inc. has announced regulatory approval for its SSi Mantra surgical robotic system in four additional countries, marking a significant expansion of the company's global footprint in medical technology. The approvals were granted by national regulatory bodies in Colombia, Oman, Sri Lanka, and Kenya between November 2025 and January 2026, positioning the company to address what it describes as underpenetrated markets with its cost-effective robotic surgery platform.
The company received approval from Colombia's Instituto Nacional de Vigilancia de Medicamentos y Alimentos in November 2025, followed by approval from Oman's Directorate General of Pharmaceutical Affairs and Drug Control that same month. In January 2026, the National Medicines Regulatory Authority in Sri Lanka and the Pharmacy and Poisons Board in Kenya granted regulatory clearance for the SSi Mantra system. These approvals allow the system to be used for multiple surgical indications in each country.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, emphasized the company's commitment to democratizing access to robotic surgery in underserved regions. "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," stated Dr. Srivastava. The company believes its system's cost advantages, combined with advanced technology features and user-friendly design, position it favorably in these markets.
The SSi Mantra system now has regulatory approval in eleven countries worldwide, including India, Ecuador, Guatemala, Indonesia, Philippines, Ukraine, and the United Arab Emirates. As of December 31, 2025, the cumulative installed base totaled 168 systems across ten countries, with 7,885 surgeries performed using the technology. These procedures included 390 cardiac surgeries and 121 pediatric operations, demonstrating the system's versatility across different surgical specialties.
Notably, more than 150 telesurgeries have been performed with the SSi Mantra system to date, leveraging its optional SSi MantrAsana Tele Surgeon Console. This portable console provides equivalent control functionality to the standard surgeon command center while enabling enhanced portability and telesurgery capability. The system's technical features include 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and the ability to superimpose 3D models of diagnostic imaging.
The company continues to pursue regulatory pathways in established markets, anticipating 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 is working toward European Union CE marking certification, which it believes can be obtained in 2026. These regulatory milestones represent significant steps toward the company's vision of making robotic surgery affordable and accessible to a larger segment of the global population.
The expansion into Colombia, Oman, Sri Lanka, and Kenya represents a strategic move to address healthcare disparities in regions where advanced surgical technologies have traditionally been less accessible. By offering a cost-effective alternative to existing robotic surgery systems, SS Innovations aims to decentralize excellence in surgical robotic care while maintaining clinical standards. The system has been clinically validated in India in more than 100 different types of surgical procedures, providing evidence of its safety and efficacy across diverse medical applications.
For more information about the company and its technologies, visit ssinnovations.com. Additional company updates and news are available through various financial and media channels that cover developments in the medical technology sector.
