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. The approvals from INVIMA in Colombia, DGPA&DC in Oman, NMRA in Sri Lanka, and PPB in Kenya bring the total number of countries where the system is approved to eleven, including India, Ecuador, Guatemala, Indonesia, Philippines, Ukraine, and the United Arab Emirates.
The SSi Mantra, a modular multi-arm robotic system designed for affordability and ease of use, is positioned to address underpenetrated markets where access to advanced surgical technology is limited. According to the company, the system's cost advantages, advanced features, and user-friendliness make it well-suited for these regions. 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 an installed base of 168 systems across ten countries, with cumulative surgeries reaching 7,885, including 390 cardiac procedures and 121 pediatric surgeries. The system has also been used in over 150 telesurgeries, highlighting its potential for remote surgical care. The company anticipates that the U.S. Food and Drug Administration will complete its review of the SSi Mantra's 510(k) premarket notification by mid-2026, and it is also pursuing CE marking certification in the European Union, which it believes could be obtained in 2026.
The SSi Mantra features three to five modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, and a virtual real-time image of the patient side arm carts. It also offers the optional SSi MantrAsana Tele Surgeon Console for enhanced portability and telesurgery capability. The system supports over 40 types of robotic endo-surgical instruments, including 5mm instruments for pediatric and ENT surgeries.
These regulatory approvals represent a strategic expansion for SS Innovations, which aims to decentralize excellence in surgical robotic care while pursuing established markets in the United States and Europe. The company's focus on affordability and accessibility aligns with the growing global demand for minimally invasive surgical options.
