Archive · 19 Dec 2025
SSi Mantra Submits Surgical Robot for FDA Approval
SS Innovations, an Indian company, has sent a request to the US FDA to approve their new surgical robot called SSi Mantra.
This robot can help with many types of surgeries like heart, stomach, and kidney surgeries.
The company's CEO, Dr. Sudhir Srivastava, is very excited because this is a big step for India to become a leader in making advanced medical technology.
If approved, this will be one of the first surgical robots made in India to be used in the US.
SS Innovations International, Inc submitted a 510(k) premarket notification for its SSi Mantra surgical robotic system to the FDA on December 5, 2025.
The system is designed for multiple surgical specialties including general, urological, colorectal, gynaecological, and cardiac procedures.
This submission marks a significant global regulatory step for an Indian-developed surgical robotic platform.
Dr. Sudhir Srivastava, CEO of SS Innovations, highlighted the milestone as a defining moment for India's emergence in advanced medical technologies.
The move aims to position India prominently in the surgical robotics sector, which has been long dominated by international players.
- Who
- SS Innovations International, Inc
- What
- Submission of 510(k) premarket notification for SSi Mantra surgical robotic system to the FDA
- When
- December 5, 2025
- Where
- United States (FDA submission)
- Why
- To position India as a global leader in advanced medical technologies and enter the US market
- Company
- SS Innovations International, Inc
- Product
- SSi Mantra surgical robotic system
- FDA Submission
- 510(k) premarket notification
- Submission Date
- December 5, 2025
- Surgical Specialties
- General, urological, colorectal, gynaecological, and cardiac procedures
- CEO
- Dr Sudhir Srivastava