SS Innovations International, Inc. has received regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya, marking a significant expansion of the company's global footprint. The approvals position the company to address what it describes as underpenetrated markets with a cost-effective robotic surgery solution. Regulatory clearances were granted by the Instituto Nacional de Vigilancia de Medicamentos y Alimentos in Colombia, the Directorate General of Pharmaceutical Affairs and Drug Control in Oman, the National Medicines Regulatory Authority in Sri Lanka, and the Pharmacy and Poisons Board in Kenya between November 2025 and January 2026.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, stated that the company aims to democratize access to cutting-edge robotic surgery for patients in underserved regions. The company believes the SSi Mantra's cost advantages, advanced technology, differentiated features, ease of training, and user-friendliness make it well-suited for these markets. This expansion occurs as SS Innovations continues to pursue regulatory pathways 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 and is working toward obtaining European Union CE marking certification this year.
The SSi Mantra is now approved in eleven countries, including India, Ecuador, Guatemala, Indonesia, the Philippines, Ukraine, and the United Arab Emirates. As of December 31, 2025, the system had an installed base of 168 units across ten countries and had been used in 7,885 cumulative surgeries. These procedures included 390 cardiac surgeries and 121 pediatric surgeries. The system has also been used in more than 150 telesurgeries to date. The SSi Mantra is a modular, multi-arm system featuring an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and support for over 40 different types of robotic endo-surgical instruments. An optional portable console, the SSi MantrAsana Tele Surgeon Console, enables telesurgery capability. More information is available on the company's website at https://ssinnovations.com.
This regulatory expansion is significant because it increases the availability of robotic surgical technology in regions where such advanced medical equipment has historically been limited due to high costs. By offering a system designed to be affordable and accessible, SS Innovations could help bridge the gap in surgical care quality between developed and developing nations. The company's focus on cost efficiency without compromising on advanced features like telesurgery capability and support for complex procedures like cardiac surgery addresses a critical need in global healthcare. As robotic surgery becomes more prevalent worldwide, approvals like these could lead to improved surgical outcomes and increased procedural options for patients in these countries.
