SS Innovations Expands Global Opportunity with Regulatory Approval of the SSi Mantra Surgical Robotic System in Colombia, Oman, Sri Lanka and Kenya
SS Innovations (Nasdaq: SSII) received regulatory approvals for the SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka and Kenya.
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Rhea-AI Summary
SS Innovations (Nasdaq: SSII) received regulatory approvals for the SSi Mantra surgical robotic system in Colombia, Oman, Sri Lanka and Kenya.
The approvals were granted by INVIMA (Colombia, Nov 2025), DGPA&DC (Oman, Nov 2025), NMRA (Sri Lanka, Jan 2026) and PPB (Kenya, Jan 2026). The SSi Mantra now has approval in eleven countries and a cumulative installed base of 168 systems with 7,885 surgeries through Dec 31, 2025.
Positive
- Regulatory approvals in Colombia, Oman, Sri Lanka and Kenya
- Approved in 11 countries, expanding global market access
- Installed base 168 systems as of Dec 31, 2025
- 7,885 cumulative surgeries performed through Dec 31, 2025
- 150+ telesurgeries demonstrating remote-use capability
Negative
- U.S. FDA 510(k) review is still pending with mid-2026 target
- European Union CE marking remains pending in 2026
- Relatively small installed base of 168 systems limits near-term revenue scale
Details
News Market Reaction – SSII
On Mar 30, the day this news came out, SSII closed 0.20% above the previous close.
Data tracked by StockTitan Argus for the Mar 30 session.
Key Figures
- Countries with approval
- 11 countries
- Total regulatory approvals for SSi Mantra to date
- Installed base
- 168 systems
- SSi Mantra cumulative installed base as of Dec 31, 2025
- Cumulative surgeries
- 7,885 surgeries
- Total SSi Mantra surgeries as of Dec 31, 2025
- Cardiac procedures
- 390 procedures
- Cumulative SSi Mantra cardiac surgeries
- Pediatric surgeries
- 121 surgeries
- Cumulative SSi Mantra pediatric procedures
- Telesurgeries performed
- more than 150
- Cumulative telesurgeries performed with SSi Mantra
- FDA review timing
- mid-2026
- Anticipated completion of 510(k) review for SSi Mantra
- EU CE marking goal
- 2026
- Company’s target timing for CE marking certification
Historical Context
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Regulatory approval for telesurgeries in Indonesia and the Philippines with >150 cases.
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Reported 2025 revenue of $42.5M, up 105.7%, and margin expansion.
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Closed $18.6M private placement of 5,774,839 shares to fund growth initiatives.
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Preliminary 2025 revenue of $43.0M and 168 installed SSi Mantra systems.
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Appointment of Milan Rao as Global COO and CFO to support scaling.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
regulatory approval regulatory
surgical robotic system medical
telesurgeries medical
510(k) premarket notification regulatory
ce marking regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
FORT LAUDERDALE, Fla., March 30, 2026 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company has received regulatory approval for the SSi Mantra surgical robotic system (the “SSi Mantra”), for multiple indications in Colombia, Oman, Sri Lanka and Kenya.
The Company received regulatory approval for the SSi Mantra from the Instituto Nacional de Vigilancia de Medicamentos y Alimentos (“INVIMA”) in Colombia in November 2025, from the Directorate General of Pharmaceutical Affairs and Drug Control (“DGPA&DC”) in Oman in November 2025, from the National Medicines Regulatory Authority (“NMRA”) in Sri Lanka in January 2026, and from the Pharmacy and Poisons Board (“PPB”) in Kenya in January 2026. SS Innovations believes that it is favorably positioned to address these underpenetrated markets given the SSi Mantra’s cost advantages combined with its advanced technology, differentiated features, ease of training, and user-friendliness.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “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. Over the past few months, our advanced, cost-efficient SSi Mantra surgical robotic system has received regulatory approval in Colombia, Oman, Sri Lanka, and Kenya. We are committed to decentralizing excellence in surgical robotic care in these new jurisdictions, among others, while pursuing the established United States and Europe Union markets. We anticipate that the U.S. Food and Drug Administration will complete its review of our 510(k) premarket notification for the SSi Mantra by mid-2026. Separately, we continue along the pathway towards a European Union CE marking certification for the SSi Mantra, which we believe we can obtain in 2026.”
To date, the SSi Mantra has been granted regulatory approval in eleven countries, including India and the following:
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As of December 31, 2025, the SSi Mantra cumulative installed base totaled 168 across ten countries and cumulative surgeries reached 7,885, including 390 cardiac procedures and 121 pediatric surgeries.
To date, more than 150 telesurgeries have been performed with the SSi Mantra.
About SS Innovations
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of robotic surgical procedures including cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.
About the SSi Mantra
The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. The optional SSi MantrAsana Tele Surgeon Console is a portable, compact alternative to the SSi Mantra’s standard surgeon command center that provides equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures.
Forward Looking Statements
This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
Investor Contact:
The Equity Group
Kalle Ahl, CFA
T: (303) 953-9878
kahl@theequitygroup.com
Devin Sullivan, Managing Director
T: (212) 836-9608
dsullivan@theequitygroup.com
Media Contact:
RooneyPartners LLC
Kate Barrette
T: (212) 223-0561
kbarrette@rooneypartners.com
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