SS Innovations International, Inc. (Nasdaq: SSII) announced today that it has received regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya, bringing the total number of countries where the system is approved to eleven. The approvals, granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in Colombia, the Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) in Oman, the National Medicines Regulatory Authority (NMRA) in Sri Lanka, and the Pharmacy and Poisons Board (PPB) in Kenya, position the company to address underpenetrated markets with its cost-efficient technology.
The SSi Mantra is a modular, multi-arm robotic system designed to make robotic surgery affordable and accessible. According to the company, its cost advantages, advanced features, ease of training, and user-friendliness make it particularly suitable for regions with limited access to surgical robotics. 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.'
As of December 31, 2025, the SSi Mantra had a cumulative installed base of 168 systems across ten countries and had been used in 7,885 surgeries, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, more than 150 telesurgeries have been performed using the system, highlighting its telesurgery capability via the optional SSi MantrAsana Tele Surgeon Console.
The company is also pursuing regulatory approvals in the United States and European Union. SS Innovations 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, and it expects to obtain CE marking certification in the European Union in 2026.
SS Innovations plans to expand the global presence of its surgical robotic solutions, which include the SSi Mantra and the SSi Mudra suite of surgical instruments. The company's focus on affordability and accessibility positions it to compete in markets traditionally dominated by higher-cost robotic systems. For more information, visit the company's website at ssinnovations.com.
