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, basic surgical procedure, and thoracic and cardiac surgical procedure.
The SSI Mantra 3 system includes 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.
Because the firm started promoting its system in August 2022, it has put in 80 SSi Mantra robotic surgical programs 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 programs. These have been utilized to carry out greater than 750 multi-specialty robotic surgical procedures, together with 70 cardiac circumstances. The corporate reviews no device-related mortality, damage, or problems.
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In response to SS Improvements, real-world scientific information validated by a number one contract analysis group helps the SSi Mantra 3’s capability to soundly carry out all kinds of surgical procedures.
“We presently have approval to market our SSi Mantra surgical robotic system in six nations and proceed to advance our world growth,” 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 aim to democratize entry to cutting-edge healthcare, Dr. Vishwa Srivastava, chief working officer of SS Improvements, instructed 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 Medication Customary 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 offers a digital real-time picture of the robotic Affected person Aspect Arm Carts and might superimpose 3D fashions of diagnostic imaging.
Editor’s Be aware: This text was syndicated from The Robotic Report’s sibling website MassDevice.