SS Innovations Gains Regulatory Approval for Surgical Robotic System in Four New Countries

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 into underpenetrated markets. The company believes its cost advantages combined with advanced technology position it favorably to address these regions where access to robotic surgery has been limited. Regulatory approvals 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 of the Board and Chief Executive Officer of SS Innovations, stated the company continues to expand its global opportunity with an eye on democratizing access to cutting-edge robotic surgery for patients in underserved regions. The company is committed to decentralizing excellence in surgical robotic care in these new jurisdictions while pursuing established markets 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 continues along the pathway toward European Union CE marking certification, which it believes can be obtained in 2026.

The SSi Mantra has now been granted regulatory approval in eleven countries, including India, Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and United Arab Emirates. As of December 31, 2025, the cumulative installed base totaled 168 systems across ten countries, with cumulative surgeries reaching 7,885 procedures. These include 390 cardiac procedures and 121 pediatric surgeries, demonstrating the system's versatility across different patient populations and surgical specialties. More than 150 telesurgeries have been performed with the SSi Mantra to date, highlighting its remote capabilities.

The SSi Mantra surgical robotic system features 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and a touch panel monitor for patient information display. The system includes the optional SSi MantrAsana Tele Surgeon Console, a portable alternative that provides equivalent control functionality while enabling enhanced portability and telesurgery capability. The robotic system utilizes over 40 different types of robotic endo-surgical instruments to support various specialties, including cardiac surgery, and 5mm instruments for pediatric and ENT surgeries. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to enhance safety and efficiency.

This expansion represents a strategic move to address healthcare disparities in regions where advanced surgical technologies have been historically inaccessible due to cost barriers. By obtaining regulatory approvals in these four countries, SS Innovations positions itself to capture market share in regions with growing healthcare infrastructure needs. The company's focus on affordability and accessibility aligns with global efforts to improve surgical care outcomes in developing economies. For more information about the company's developments, visit https://tinyurl.com/ssiinewsroom where updates are regularly posted.