HT Bureau
GUWAHATI, Dec 22: India’s homegrown surgical robotics company SS Innovations International has taken a major step onto the global regulatory stage with the filing of a 510(k) premarket notification with the US Food and Drug Administration for its next-generation SSi Mantra surgical robotic system.
The submission, completed on December 5, 2025, covers multiple high-demand surgical specialties, including general surgery, urology, colorectal surgery, gynaecology and cardiac procedures.
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The move marks one of the most significant regulatory milestones achieved so far by an Indian-developed surgical robotic platform in a sector traditionally dominated by global players.
Dr Sudhir Srivastava, Founder, Chairman and CEO of SS Innovations, described the filing as a defining moment for both the company and India’s medical technology ecosystem.
He said the SSi Mantra has been designed to be affordable, accessible and technologically differentiated, with the potential to benefit hospitals, particularly those serving underserved communities, by offering a cost-effective, world-class alternative.
After pre-submission meetings and detailed consultations with the FDA, the company chose the 510(k) pathway instead of the De Novo route, aiming to leverage a potentially faster and more efficient approval process.
The FDA’s target review timeline for 510(k) applications is 90 days, although the overall duration may vary. SS Innovations is also progressing towards European Union CE marking, which is expected in the first half of 2026.
As of November 30, 2025, the SSi Mantra platform has recorded 138 installations across eight countries and is in active use at 137 hospitals.
More than 7,300 surgical procedures have been performed using the system, including 88 telesurgeries and 390 cardiac surgeries, one of the most technically complex domains in robotic surgery.
Industry observers say the growing adoption of the SSi Mantra reflects increasing global confidence in India’s indigenous med-tech capabilities and represents a significant inflection point for the country’s medical devices and robotics sector.
