SS Innovations International, Inc. (Nasdaq: SSII) announced regulatory approvals for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya, marking a significant expansion of its global footprint. The approvals from INVIMA in Colombia, DGPA&DC in Oman, NMRA in Sri Lanka, and PPB in Kenya position the company to address underpenetrated markets where cost-effective robotic surgery is in high demand.
Dr. Sudhir Srivastava, Chairman and CEO of SS Innovations, emphasized the company's commitment to democratizing access to robotic surgery. '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 said. 'We are committed to decentralizing excellence in surgical robotic care in these new jurisdictions, among others, while pursuing the established United States and European Union markets.'
The SSi Mantra has now received regulatory approval 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 cumulative installed base totaled 168 systems across ten countries, with cumulative surgeries reaching 7,885, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, more than 150 telesurgeries have been performed with the system.
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. Separately, SS Innovations continues its pathway toward European Union CE marking certification, which it believes can be obtained in 2026.
The SSi Mantra is a user-friendly, modular, multi-arm system with advanced features including 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and the ability for superimposition of 3D models of diagnostic imaging. The optional SSi MantrAsana Tele Surgeon Console enables enhanced portability, ergonomic flexibility, and telesurgery capability. The system utilizes over 40 different types of robotic endo-surgical instruments and has been clinically validated in India in more than 100 different types of surgical procedures.
For more information about SS Innovations and the SSi Mantra, visit the company's website at ssinnovations.com or follow on LinkedIn.
