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SS Innovations Submits FDA Application for Robotic System

Story Highlights
  • SS Innovations submitted a 510(k) notification to the FDA for its SSi Mantra system.
  • The company aims to expand its market presence in the U.S. and Europe with its cost-efficient robotic system.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
SS Innovations Submits FDA Application for Robotic System

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SS Innovations International ( (SSII) ) has provided an announcement.

On December 8, 2025, SS Innovations International announced the submission of a 510(k) premarket notification to the FDA for its SSi Mantra surgical robotic system, targeting multiple specialties such as general, urological, and cardiac surgeries. This strategic move aims to introduce the cost-efficient system to the U.S. market, enhancing its appeal to hospitals and surgeons, particularly in underserved communities. The company is also progressing towards obtaining a European Union CE marking certification by the first half of 2026. As of November 30, 2025, the SSi Mantra has been installed in 138 systems across eight countries, with over 7,300 surgical procedures performed, highlighting its growing global footprint.

The most recent analyst rating on (SSII) stock is a Hold with a $6.00 price target. To see the full list of analyst forecasts on SS Innovations International stock, see the SSII Stock Forecast page.

Spark’s Take on SSII Stock

According to Spark, TipRanks’ AI Analyst, SSII is a Neutral.

SS Innovations International’s stock score is primarily influenced by its strong corporate events, which highlight significant growth and innovation. However, financial performance and valuation scores are low due to ongoing profitability challenges and a negative P/E ratio. Technical analysis indicates a bearish trend, further impacting the overall score.

To see Spark’s full report on SSII stock, click here.

More about SS Innovations International

SS Innovations International, Inc. (Nasdaq: SSII) is a developer of innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally. The company’s product line includes the proprietary ‘SSi Mantra’ surgical robotic system and a comprehensive suite of ‘SSi Mudra’ surgical instruments, supporting various surgical procedures, including robotic cardiac surgery. Headquartered in India, SS Innovations seeks to expand its global presence with its advanced, user-friendly, and cost-effective solutions.

Average Trading Volume: 95,980

Technical Sentiment Signal: Sell

Current Market Cap: $1.2B

For an in-depth examination of SSII stock, go to TipRanks’ Overview page.

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