SS Innovations International, Inc. (SSII) filed a 510(k) pre‑market notification with the U.S. Food and Drug Administration on December 5 2025, a move that positions the company to bring its SSi Mantra surgical robotic system into the world’s largest medical‑device market. The filing covers a broad range of indications—including general, urological, colorectal, gynecological, and cardiac procedures—underscoring the platform’s versatility.
The company’s strategy to pursue the 510(k) pathway, rather than a De Novo request, reflects a desire for a faster and more cost‑effective route to clearance. SSII also continues to chase European Union CE marking, with approval expected in the first half of 2026, which will give the system a dual‑market launch in the near term.
As of November 30 2025, the SSi Mantra had 138 units installed across eight countries and had supported more than 7,300 procedures, including 88 telesurgeries and 390 cardiac operations. This global footprint demonstrates the platform’s proven performance and provides a strong foundation for U.S. adoption, where the company aims to compete with established players such as Intuitive Surgical by offering a more affordable, modular solution that can serve underserved hospitals and surgeons.
Financially, SSII has achieved a 158% year‑over‑year revenue increase in the last twelve months, although it remains unprofitable with a negative EBITDA of $8.39 million. The company’s focus on cost efficiency and modular design is intended to drive margin improvement as volume grows, while the 510(k) clearance is expected to accelerate revenue expansion in the U.S. market.
Dr. Sudhir Srivastava, Chairman and CEO, said the filing “marks an important milestone in our strategic plan to introduce the SSi Mantra to the U.S. market. Its affordability, differentiated technology, and proven performance across our global installations make it a compelling option for hospitals and surgeons, especially those serving underserved communities.”
The FDA submission signals a critical step toward unlocking new revenue streams for SSII and positions the company to capture a share of the competitive U.S. surgical‑robotics landscape. Successful clearance will enable the firm to leverage its existing global experience, scale its modular platform, and pursue growth in both high‑volume specialty areas and remote telesurgery applications.
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