SS Innovations Submits FDA 510(k) for SSi Mantra Surgical Robot
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 08 2025
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Should l Buy SSII?
Source: Newsfilter
- Significant Milestone: On December 5, 2025, SS Innovations submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical robotic system, marking a crucial step in the company's strategy to introduce advanced, cost-effective robotic surgery technology to the U.S. market.
- Market Potential: The SSi Mantra system has received regulatory approval in 138 installations across eight countries, with over 7,300 surgical procedures performed in 137 hospitals, demonstrating its extensive applicability in the global market.
- Accelerated Approval Pathway: The company opted for a 510(k) submission instead of a De Novo request to leverage the FDA's goal of completing reviews within 90 days, aiming to expedite the product's market entry.
- EU Certification Progress: SS Innovations is also advancing towards obtaining CE marking for the SSi Mantra in the European Union, which it expects to achieve in the first half of 2026, further enhancing its strategic positioning in international markets.
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Analyst Views on SSII
About SSII
SS Innovations International, Inc. is a developer of surgical robotic technologies. The Company’s product range includes its proprietary SSi Mantra surgical robotic system and its comprehensive suite of SSi Mudra surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. The SSi Mantra Surgical Robotic System is designed to enable surgeons to perform a wide range of surgical procedures including cardiovascular, thoracic, head and neck, gynecological, urological, cancer and general surgeries. The SSi Mantra 3 is comprised of components, such as Surgeon Console, Patient-Side Robotic Arm Carts, and Vision Cart. Its instruments under development include NADI-Automated Coronary Anastomotic Connector, SSi Multi-Fire Clip Applier, SSi Ultrasonic Surgical Device, SSi Maya-XR Pre-Operative Simulator, SSi Holographic Anatomy, SSi Yog-Tele Proctor, SSi Chitrasa-Advanced DICOM Viewer and SSi Mixed Reality Headset.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
SS Innovations Reports Q4 2025 Revenue of $15M, Up 85% Year-over-Year
- Significant Revenue Growth: SS Innovations anticipates Q4 2025 revenue of approximately $15 million, representing an 85% increase from $8.1 million in Q4 2024, showcasing strong performance in the global market.
- Increased System Installations: By the end of Q4 2025, the number of SSi Mantra surgical robot installations rose to 37, up from 22 in the same quarter last year, reflecting a sustained demand for its products.
- Impressive Annual Performance: Full-year 2025 revenue is projected to reach $43 million, a 108% increase from $20.6 million in 2024, with annual installations totaling 103, significantly up from 47 in 2024, bringing the cumulative installed base to 168 systems.
- Positive Future Outlook: The company expects to complete the FDA 510(k) review for the SSi Mantra system in the first half of 2026, while also advancing towards EU CE Mark certification in the same timeframe, further solidifying its market position.
See More
SS Innovations (SSII) Expects 2025 Revenue of $43 Million, Up 108%
- Significant Revenue Growth: SS Innovations anticipates fourth-quarter 2025 revenue of approximately $15 million, an 85% increase from $8.1 million in the fourth quarter of 2024, indicating strong performance driven by rising market demand.
- Installation Numbers Surge: The company expects to report 37 SSi Mantra installations in Q4 2025, up 68% from 22 installations in Q4 2024, reflecting increasing acceptance and demand for its products in the global market.
- Annual Performance Breakthrough: For the full year 2025, SS Innovations projects revenue of approximately $43 million, an increase of 108% from $20.6 million in 2024, showcasing a significant enhancement in market share and sales capabilities in the surgical robotics sector.
- Market Expansion Plans: The company aims to complete FDA review and EU CE certification for the SSi Mantra in the first half of 2026, further driving its expansion in the U.S. and European markets and enhancing its global competitiveness.
See More
SS Innovations Appoints Milan Rao as Global COO and CFO Amid Leadership Transition
- Executive Appointment: SS Innovations announces the appointment of Milan Rao as Global Chief Operating Officer and Chief Financial Officer, succeeding Naveen Kumar Amar who resigned for personal reasons, marking a strategic leadership transition for the company.
- New Role Creation: The establishment of the Global COO position aims to enhance operational efficiency and technological transformation as the company expands the global footprint of its advanced SSi Mantra surgical robotic system.
- Extensive Experience: Milan Rao brings over three decades of executive leadership experience, having driven technology-enabled transformation and growth at leading global companies across various industries, which is expected to strengthen SS Innovations' financial and operational management capabilities.
- Strategic Development: Rao's appointment reflects the company's commitment to attracting top talent, aiming to leverage his leadership to democratize robotic surgery and meet the needs of a broader patient population.
See More
SS Innovations International (SSII) Moves into Oversold Zone
SS Innovations International Inc Performance: SS Innovations International Inc (SSII) shares have entered oversold territory with an RSI of 26.7, trading as low as $5.41 per share, compared to the S&P 500 ETF's RSI of 48.9.
Potential Buying Opportunity: The low RSI reading may indicate that heavy selling is exhausting, suggesting potential buying opportunities for bullish investors.
52-Week Range: SSII's 52-week low is $3.015 and the high is $15.50, with the last trade recorded at $5.45.
Disclaimer: The views expressed in the article are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
See More
SS Innovations Submits FDA 510(k) for SSi Mantra Surgical Robot
- Significant Milestone: On December 5, 2025, SS Innovations submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical robotic system, marking a crucial step in the company's strategy to introduce advanced, cost-effective robotic surgery technology to the U.S. market.
- Market Potential: The SSi Mantra system has received regulatory approval in 138 installations across eight countries, with over 7,300 surgical procedures performed in 137 hospitals, demonstrating its extensive applicability in the global market.
- Accelerated Approval Pathway: The company opted for a 510(k) submission instead of a De Novo request to leverage the FDA's goal of completing reviews within 90 days, aiming to expedite the product's market entry.
- EU Certification Progress: SS Innovations is also advancing towards obtaining CE marking for the SSi Mantra in the European Union, which it expects to achieve in the first half of 2026, further enhancing its strategic positioning in international markets.
See More
SSII Falls Below Important Moving Average Threshold
- 52 Week Range: SSII's stock has a 52-week low of $2.48 and a high of $15.50, with the last trade recorded at $7.72.
- Market Analysis: The article mentions other stocks that have recently fallen below their 200-day moving average.
- Author's Perspective: The views expressed in the article are solely those of the author and do not necessarily represent Nasdaq, Inc.
- Stock Performance Insight: The information highlights the volatility and performance range of SSII's stock over the past year.
See More
SS Innovations Reports Q4 2025 Revenue of $15M, Up 85% Year-over-Year
- Significant Revenue Growth: SS Innovations anticipates Q4 2025 revenue of approximately $15 million, representing an 85% increase from $8.1 million in Q4 2024, showcasing strong performance in the global market.
- Increased System Installations: By the end of Q4 2025, the number of SSi Mantra surgical robot installations rose to 37, up from 22 in the same quarter last year, reflecting a sustained demand for its products.
- Impressive Annual Performance: Full-year 2025 revenue is projected to reach $43 million, a 108% increase from $20.6 million in 2024, with annual installations totaling 103, significantly up from 47 in 2024, bringing the cumulative installed base to 168 systems.
- Positive Future Outlook: The company expects to complete the FDA 510(k) review for the SSi Mantra system in the first half of 2026, while also advancing towards EU CE Mark certification in the same timeframe, further solidifying its market position.
See More
SS Innovations (SSII) Expects 2025 Revenue of $43 Million, Up 108%
- Significant Revenue Growth: SS Innovations anticipates fourth-quarter 2025 revenue of approximately $15 million, an 85% increase from $8.1 million in the fourth quarter of 2024, indicating strong performance driven by rising market demand.
- Installation Numbers Surge: The company expects to report 37 SSi Mantra installations in Q4 2025, up 68% from 22 installations in Q4 2024, reflecting increasing acceptance and demand for its products in the global market.
- Annual Performance Breakthrough: For the full year 2025, SS Innovations projects revenue of approximately $43 million, an increase of 108% from $20.6 million in 2024, showcasing a significant enhancement in market share and sales capabilities in the surgical robotics sector.
- Market Expansion Plans: The company aims to complete FDA review and EU CE certification for the SSi Mantra in the first half of 2026, further driving its expansion in the U.S. and European markets and enhancing its global competitiveness.
See More
SS Innovations Appoints Milan Rao as Global COO and CFO Amid Leadership Transition
- Executive Appointment: SS Innovations announces the appointment of Milan Rao as Global Chief Operating Officer and Chief Financial Officer, succeeding Naveen Kumar Amar who resigned for personal reasons, marking a strategic leadership transition for the company.
- New Role Creation: The establishment of the Global COO position aims to enhance operational efficiency and technological transformation as the company expands the global footprint of its advanced SSi Mantra surgical robotic system.
- Extensive Experience: Milan Rao brings over three decades of executive leadership experience, having driven technology-enabled transformation and growth at leading global companies across various industries, which is expected to strengthen SS Innovations' financial and operational management capabilities.
- Strategic Development: Rao's appointment reflects the company's commitment to attracting top talent, aiming to leverage his leadership to democratize robotic surgery and meet the needs of a broader patient population.
See More
SS Innovations International (SSII) Moves into Oversold Zone
SS Innovations International Inc Performance: SS Innovations International Inc (SSII) shares have entered oversold territory with an RSI of 26.7, trading as low as $5.41 per share, compared to the S&P 500 ETF's RSI of 48.9.
Potential Buying Opportunity: The low RSI reading may indicate that heavy selling is exhausting, suggesting potential buying opportunities for bullish investors.
52-Week Range: SSII's 52-week low is $3.015 and the high is $15.50, with the last trade recorded at $5.45.
Disclaimer: The views expressed in the article are those of the author and do not necessarily reflect the opinions of Nasdaq, Inc.
See More
SS Innovations Submits FDA 510(k) for SSi Mantra Surgical Robot
- Significant Milestone: On December 5, 2025, SS Innovations submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical robotic system, marking a crucial step in the company's strategy to introduce advanced, cost-effective robotic surgery technology to the U.S. market.
- Market Potential: The SSi Mantra system has received regulatory approval in 138 installations across eight countries, with over 7,300 surgical procedures performed in 137 hospitals, demonstrating its extensive applicability in the global market.
- Accelerated Approval Pathway: The company opted for a 510(k) submission instead of a De Novo request to leverage the FDA's goal of completing reviews within 90 days, aiming to expedite the product's market entry.
- EU Certification Progress: SS Innovations is also advancing towards obtaining CE marking for the SSi Mantra in the European Union, which it expects to achieve in the first half of 2026, further enhancing its strategic positioning in international markets.
See More
SSII Falls Below Important Moving Average Threshold
- 52 Week Range: SSII's stock has a 52-week low of $2.48 and a high of $15.50, with the last trade recorded at $7.72.
- Market Analysis: The article mentions other stocks that have recently fallen below their 200-day moving average.
- Author's Perspective: The views expressed in the article are solely those of the author and do not necessarily represent Nasdaq, Inc.
- Stock Performance Insight: The information highlights the volatility and performance range of SSII's stock over the past year.
See More
