SS Innovations International, Inc. (Nasdaq: SSII), a developer of surgical robotic technologies, announced today that it has received regulatory approval for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya. These approvals expand the company's global footprint and align with its mission to make robotic surgery affordable and accessible worldwide.
The Colombian approval came from the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA) in November 2025. The Directorate General of Pharmaceutical Affairs and Drug Control (DGPA&DC) in Oman granted approval in November 2025. Sri Lanka's National Medicines Regulatory Authority (NMRA) approved the system in January 2026, followed by Kenya's Pharmacy and Poisons Board (PPB) in January 2026. SS Innovations believes its cost advantages, advanced technology, and ease of use position it well to address these underpenetrated markets.
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.' He noted that the company remains committed to decentralizing excellence in surgical robotic care in these new jurisdictions while also pursuing the established U.S. and European Union markets. Dr. Srivastava anticipates that the U.S. Food and Drug Administration will complete its review of the company's 510(k) premarket notification for the SSi Mantra by mid-2026, and that European Union CE marking certification could be obtained in 2026.
With these new approvals, the SSi Mantra has now been granted regulatory clearance in eleven countries, including India, Colombia, Ecuador, Guatemala, Indonesia, Kenya, Oman, Philippines, Sri Lanka, Ukraine, and the United Arab Emirates. As of December 31, 2025, the SSi Mantra cumulative installed base totaled 168 across ten countries, and cumulative surgeries reached 7,885, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, more than 150 telesurgeries have been performed with the system.
The SSi Mantra is a modular, multi-arm robotic system featuring 3 to 5 robotic arms, an open-faced ergonomic surgeon console, a large 3D 4K monitor, and a touch panel for patient information. It includes a virtual real-time image of the patient-side arm carts and the ability to superimpose 3D diagnostic imaging models. The optional SSi MantrAsana Tele Surgeon Console offers portability and telesurgery capabilities. The system supports over 40 different robotic endo-surgical instruments, including 5mm instruments for pediatric and ENT surgeries. It has been clinically validated in India in more than 100 different types of surgical procedures.
SS Innovations, an American company headquartered in India, continues to expand its global presence with cost-effective surgical robotic solutions. For more information, visit the company's website at ssinnovations.com or its LinkedIn page.
