regulatory
confidence high
sentiment positive
materiality 0.60
SSi Mantra approved in Colombia, Oman, Sri Lanka, Kenya; total approvals now 11 countries
SS Innovations International, Inc.
- Regulatory approvals from INVIMA (Colombia, Nov 2025), DGPA&DC (Oman, Nov 2025), NMRA (Sri Lanka, Jan 2026), and PPB (Kenya, Jan 2026).
- Cumulative installed base of SSi Mantra reached 168 systems across 10 countries as of Dec 31, 2025.
- Cumulative surgeries total 7,885 including 390 cardiac and 121 pediatric; over 150 telesurgeries performed.
- Company anticipates FDA 510(k) decision by mid-2026 and CE marking in 2026 for SSi Mantra.