# SS Innovations Submits FDA Response for SSi Mantra Surgical Robot

- URL: https://stocks.freetheai.org/news/ss-innovations-submits-fda-response-for-ssi-mantra-surgical-robot-3988ac
- Published: 2026-10-13T12:30:00Z
- Category: company_news; sentiment: mixed; impact: medium
- Symbols: [NASDAQ:SSII](https://stocks.freetheai.org/symbols/NASDAQ-SSII)
- Written by our AI from expert market sources across the web for FreeTheAI Stocks, built by Vibhek Soni
- How write-ups are made: https://stocks.freetheai.org/how-we-write
- Not financial advice: https://stocks.freetheai.org/disclaimer

SS Innovations International, Inc. (SSII) has submitted its response to an FDA request for additional information regarding its 510(k) submission for the SSi Mantra surgical robot. The filing incorporates final findings from expanded validation and bridging studies designed to address safety, usability, and device equivalence.

The submission marks a necessary regulatory step toward bringing the SSi Mantra to the U.S. market. The final validation study data targets key safety and operational questions required for market clearance, while the bridging study results aim to establish equivalence to predicate surgical systems. If cleared, the initial commercial indication for the device will be cholecystectomy procedures.

The company expects the FDA to finish reviewing the submission in the first quarter of 2027. Investors will be monitoring that timeframe for potential regulatory clearance, along with any subsequent commercialization progress or hospital adoption milestones. Meanwhile, shares of SS Innovations International, Inc. fell 3.59% to $2.55 today.

## Key points

- SS Innovations International, Inc. (SSII) submitted its response to an FDA request for additional information for the SSi Mantra surgical robot 510(k) application.
- The filing features final data from expanded validation and bridging studies to evaluate safety, usability, and equivalence to predicate devices.
- The FDA review process for the SSi Mantra system is expected to conclude in the first quarter of 2027.
- Cholecystectomy is planned as the initial commercial indication if regulatory clearance is granted.

## Questions and answers

### What did SS Innovations submit to the FDA?

SS Innovations submitted a response to the FDA's request for additional information regarding its 510(k) application for the SSi Mantra surgical robot, including final validation and bridging study data.

### When is FDA review for the SSi Mantra expected to complete?

SS Innovations expects the FDA review for the SSi Mantra surgical robot to be completed in the first quarter of 2027.

### What is the initial medical use for the SSi Mantra robot?

If cleared by the FDA, the initial commercial indication for the SSi Mantra surgical robot will be cholecystectomy.