SS Innovations Secures SSi Mantra Approval in 4 New Markets, Expands to 11 Countries
SS Innovations won regulatory approvals for its SSi Mantra robotic surgery system in Colombia, Oman, Sri Lanka and Kenya, bringing its total approved markets to eleven countries. By December 2025 the installed base reached 168 units performing 7,885 surgeries, bolstering the company's global expansion and revenue potential.
1. Regulatory Approvals in New Markets
SS Innovations received regulatory clearance for its SSi Mantra surgical robotic system from INVIMA in Colombia and DGPA&DC in Oman in November 2025, followed by NMRA in Sri Lanka and PPB in Kenya in January 2026. These approvals expand the robot’s footprint into underpenetrated regions with strong demand for cost-effective surgical technology.
2. Installed Base and Surgical Procedures
As of December 31, 2025, the SSi Mantra has accumulated an installed base of 168 units across ten countries, with 7,885 total surgeries performed, including 390 cardiac and 121 pediatric procedures. The system has also enabled over 150 telesurgeries, demonstrating both clinical versatility and growing market adoption.
3. Upcoming U.S. and EU Certifications
The company anticipates completion of the U.S. FDA 510(k) review by mid-2026 and is pursuing a European Union CE marking certification later in 2026. Securing these certifications would open two of the world’s largest healthcare markets for its surgical robotics franchise.