SS Innovations Announces Regulatory Approval of the SSi Mantra Surgical Robotic System in Colombia, Oman, Sri Lanka and Kenya

SS Innovations International has 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:

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.

Source: SS Innovations

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