SS Innovations International, Inc. (Nasdaq: SSII), a developer of surgical robotic technologies, announced today that its SSi Mantra surgical robotic system has received regulatory approval 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, obtained between November 2025 and January 2026, allow the company to market the system for multiple indications in these countries.
The company believes its system is well-suited for these underpenetrated markets due to its cost advantages, advanced technology, and ease of training. 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 added that the company is committed to decentralizing excellence in surgical robotic care while pursuing the U.S. and European Union markets, with an anticipated FDA decision on its 510(k) premarket notification by mid-2026 and a CE marking certification expected in 2026.
With these four new approvals, the SSi Mantra is now approved 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 system had an installed base of 168 units across ten countries, with cumulative surgeries reaching 7,885, including 390 cardiac procedures and 121 pediatric surgeries. Additionally, over 150 telesurgeries have been performed using the SSi Mantra.
The SSi Mantra is a modular, multi-arm system featuring 3 to 5 robotic arms, an open-faced surgeon command center, a 3D 4K monitor, and optional telesurgery capability via the SSi MantrAsana Tele Surgeon Console. It supports over 40 different robotic endo-surgical instruments, including 5mm instruments for pediatric and ENT surgeries, and has been clinically validated in more than 100 surgical procedures in India.
These regulatory approvals represent a strategic expansion for SS Innovations, positioning the company to address the growing demand for affordable surgical robotics in emerging markets. For more information about SS Innovations and its products, visit the company's website at ssinnovations.com or follow updates on LinkedIn.
