SS Innovations International, Inc. (Nasdaq: SSII), a developer of surgical robotic technologies, announced regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya. The approvals from INVIMA in Colombia, DGPA&DC in Oman, NMRA in Sri Lanka, and the Pharmacy and Poisons Board in Kenya mark a significant expansion of the company's global footprint, bringing the total number of countries where the SSi Mantra is approved to eleven.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, emphasized the company's mission to democratize access to robotic surgery. "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," he said. The SSi Mantra's cost advantages, combined with its advanced technology and ease of training, position the company to address these underpenetrated markets effectively.
The SSi Mantra is a modular, multi-arm robotic system featuring 3 to 5 robotic arms, an open-faced ergonomic surgeon console, a 3D 4K monitor, and telesurgery capabilities. As of December 31, 2025, the cumulative installed base reached 168 systems across ten countries, with cumulative surgeries totaling 7,885, including 390 cardiac procedures and 121 pediatric surgeries. Notably, over 150 telesurgeries have been performed using the SSi Mantra.
SS Innovations is also pursuing regulatory approvals in established markets. 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. Additionally, the company continues its pathway toward European Union CE marking certification, which it believes can be obtained in 2026.
The regulatory approvals in Colombia, Oman, Sri Lanka, and Kenya represent a strategic move to decentralize excellence in surgical robotic care. The SSi Mantra's affordability and user-friendliness make it particularly suitable for healthcare systems in these regions, where access to advanced surgical technology has been limited. The company's commitment to expanding global access aligns with its vision to make robotic surgery affordable and accessible to a larger segment of the global population.
For more information about SS Innovations and the SSi Mantra, visit the company's website at ssinnovations.com or follow on LinkedIn.
