Levita Magnetics has received expanded FDA 510(k) clearance for its MARS (magnetic-assisted robotic surgery) system, specifically in bariatric and hiatal hernia repair.
The clearance allows for the use of the Magnetic Surgical System (MSS) combined with MARS, offering a less invasive solution for simultaneous treatment of hiatal hernias during bariatric surgery.
The MARS system incorporates Dynamic Magnetic Positioning technology, enabling improved visibility and access during hiatal hernia repairs by retracting the liver.
Levita Magnetics also obtained FDA clearance for its new 12.5 mm magnetic grasper, enhancing visualization and control in patients with high BMI and difficult-to-retract livers.
MARS utilizes magnetic forces for organ repositioning internally, reducing incisions and providing enhanced control during laparoscopic procedures.
The system is designed to be compact, fitting into existing operating rooms, and builds on the success of Levita's Magnetic Surgical System.
Levita Magnetics previously won a 2025 RBR50 Robotics Innovation Award for a dual-robot surgery combining the MARS platform with Intuitive Surgical's Da Vinci SP robot.
The collaboration enabled precise tissue retraction, increased visualization, and nerve preservation during a complex urological surgery.
The Da Vinci SP robot creates an incision for surgical access, while the MARS system enhances access and visualization within the body.
Levita's commitment to expanding access to better surgery was emphasized by Dr. Alberto Rodriguez-Navarro, the company's founder and CEO.
The innovative technology of MARS offers a more effective and less invasive option for abdominal surgeries.
Levita aims to empower surgeons with increased control of surgical instruments through its magnetic-assisted robotic surgery system.
The post was originally published on MassDevice and discusses the advancements in Levita Magnetics' MARS surgical robot system receiving expanded FDA clearance.
The Robot Report covered the news regarding the FDA clearance of Levita Magnetics' MARS surgical robot.
Levita Magnetics continues to push boundaries in surgical robotics with its magnetic technology-led advancements.