The SSi Mantra 3 consists of 40+ robotic surgical devices that can be utilized for various specialties together with cardiac surgical procedure. | Supply: SS Improvements
SS Improvements 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 Improvements plans to submit in July. The submission will embody an software for multi-specialty indications, together with urology, gynecology, common surgical procedure, and thoracic and cardiac surgical procedure.
The SSI Mantra 3 system contains a modular, open-console design with 3D visualization and enhanced ergonomics. Built-in machine studying fashions additional improve procedural security and effectivity. Surgical robotics consultants have described SS Improvements as an organization to look at.
For the reason that firm started promoting its system in August 2022, it has put in 80 SSi Mantra robotic surgical techniques in 75 hospitals. Over 3,800 surgical procedures have been carried out, together with over 200 robotic cardiac surgical procedures.
The SSi Mantra 3 model was launched in June 2024, and SS Improvements has already put in 37 techniques. These have been utilized to carry out greater than 750 multi-specialty robotic surgical procedures, together with 70 cardiac circumstances. The corporate studies no device-related mortality, harm, or problems.
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Based on SS Improvements, real-world medical knowledge validated by a number one contract analysis group helps the SSi Mantra 3’s means to securely carry out all kinds of surgical procedures.
“We presently have approval to market our SSi Mantra surgical robotic system in six international locations and proceed to advance our international enlargement,” Sudhir Srivastava, board chair and CEO of SS Improvements, mentioned in a information launch.
“We’re taking essential steps, together with the deliberate de novo software to the FDA, to introduce our empowering, cost-effective surgical robotic expertise to the U.S. market. In parallel, we’re pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and sit up for our future with nice confidence.”
SS Improvements bets on robotic telesurgery
Earlier this 12 months, SS Improvements accomplished 5 robotic cardiac telesurgeries, of accelerating complexity, throughout greater than 250 km (155 mi.). These procedures are simply an early step in its purpose to democratize entry to cutting-edge healthcare, Dr. Vishwa Srivastava, chief working officer of SS Improvements, informed The Robotic Report in February.
The corporate’s newest system, the SSI Mantra 3, is cheaper Intuitive Surgical’s da Vinci system. Launched in July 2024, SSI Mantra 3 obtained regulatory approval for distant surgical procedure and teleproctoring from the Central Medicine Commonplace Management Group (CDSCO), opening the door for distant surgical procedures and medical schooling.
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 show all patient-related data. It additionally gives a digital real-time picture of the robotic Affected person Aspect Arm Carts and may superimpose 3D fashions of diagnostic imaging.
Editor’s Word: This text was syndicated from The Robotic Report’s sibling website MassDevice.
