SS Innovations to submit SSi Mantra 3 to FDA in July

The SSi Mantra 3 includes 40+ robotic surgical instruments that can be used for different specialties including cardiac surgery. | Source: SS Innovations

SS Innovations plans to submit a de novo classification request to the U.S. FDA for its SSi Mantra 3 surgical robotic system. Fort Lauderdale, Florida-based SS Innovations plans to submit in July. The submission will include an application for multi-specialty indications, including urology, gynecology, general surgery, and thoracic and cardiac surgery.

The SSI Mantra 3 system features a modular, open-console design with 3D visualization and enhanced ergonomics. Integrated machine learning models further enhance procedural safety and efficiency. Surgical robotics experts have described SS Innovations as a company to watch.

Since the company began selling its system in August 2022, it has installed 80 SSi Mantra robotic surgical systems in 75 hospitals. Over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries.

The SSi Mantra 3 version was launched in June 2024, and SS Innovations has already installed 37 systems. These have been utilized to perform more than 750 multi-specialty robotic surgical procedures, including 70 cardiac cases. The company reports no device-related mortality, injury, or complications.

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According to SS Innovations, real-world clinical data validated by a leading contract research organization supports the SSi Mantra 3’s ability to safely perform a wide variety of surgical procedures.

“We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion,” Sudhir Srivastava, board chair and CEO of SS Innovations, said in a news release.

“We are taking important steps, including the planned de novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.”

SS Innovations bets on robotic telesurgery

Earlier this year, SS Innovations completed five robotic cardiac telesurgeries, of increasing complexity, across more than 250 km (155 mi.). These procedures are just an early step in its goal to democratize access to cutting-edge healthcare, Dr. Vishwa Srivastava, chief operating officer of SS Innovations, told The Robot Report in February.

The company’s latest system, the SSI Mantra 3, is less expensive Intuitive Surgical’s da Vinci system. Released in July 2024, SSI Mantra 3 received regulatory approval for remote surgery and teleproctoring from the Central Drugs Standard Control Organization (CDSCO), opening the door for remote surgeries and medical education.

The system has an open-faced ergonomic Surgeon Command Centre, a 32-in. 3D 4K monitor, and a 23-in. 2D touch-panel monitor to display all patient-related information. It also provides a virtual real-time image of the robotic Patient Side Arm Carts and can superimpose 3D models of diagnostic imaging.

Editor’s Note: This article was syndicated from The Robot Report’s sibling site MassDevice. 

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