SS Innovations International, Inc. received regulatory approvals for its SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka, and Kenya, expanding access to four additional countries.
Key takeaways
Received regulatory approvals for SSi Mantra from INVIMA (Colombia, Nov 2025), DGPA&DC (Oman, Nov 2025), NMRA (Sri Lanka, Jan 2026), and PPB (Kenya, Jan 2026).
SSi Mantra now approved in 11 countries including India, Ecuador, Philippines, Guatemala, Indonesia, Ukraine, UAE.
Cumulative installed base of 168 systems across 10 countries as of Dec 31, 2025, with 7,885 surgeries including 390 cardiac and 121 pediatric.
Over 150 telesurgeries performed to date.
Anticipates FDA 510(k) review completion by mid-2026 and EU CE marking in 2026.