Levita Magnetics this week introduced it acquired expanded FDA 510(ok) clearance for its MARS (magnetic-assisted robotic surgical procedure) system.
The FDA granted 510(ok) clearance for its Magnetic Surgical System (MSS), mixed with MARS, in bariatric and hiatal hernia restore. Mountain View, California-based Levita stated the expanded indication reinforces its capacity to help surgeons treating sufferers with obesity-related circumstances. It gives a much less invasive answer that allows simultaneous therapy of hiatal hernias throughout bariatric surgical procedure.
FDA clearance permits clinicians to make use of the MARS system’s Dynamic Magnetic Positioning expertise. This retracts the liver and enhances visibility and entry throughout hiatal hernia repairs. Clearance presents an modern, much less invasive possibility for belly surgical procedure and paves the way in which for broader adoption of the expertise, Levita stated.
“This milestone reinforces our dedication to increasing entry to higher surgical procedure,” stated Dr. Alberto Rodriguez-Navarro, founder and CEO of Levita Magnetics. “We’re constructing a future the place much less invasive means simpler.”
Moreover, the FDA gave the inexperienced gentle to the corporate’s new 12.5 mm magnetic grasper. Levita engineered the grasper to enhance visualization and management in sufferers with excessive BMI and enormous or difficult-to-retract livers. The machine permits surgeons to understand the liver extra centrally, fairly than from the sting. This improves surgical entry in each hernia and bariatric procedures.
MARS introduces a brand new paradigm of robotic surgical procedure, utilizing magnetic expertise to reposition organs internally. It reduces the variety of incisions and permits full management throughout laparoscopic procedures.
Levita Magnetics’ MARS system makes use of magnetic forces to regulate a grasper instrument inside a affected person. | Credit score: Levita Magnetics
The system is available in a compact footprint designed to suit into current working rooms. It builds on the success of the corporate’s first industrial product, the Levita Magnetic Surgical System. Levita designed MARS to ship the identical affected person advantages whereas empowering surgeons with elevated management of surgical devices.
Levita Magnetics gained a 2025 RBR50 Robotics Innovation Award for a dual-robot surgical procedure that efficiently eliminated a human prostate. The process used the MARS platform to maneuver inside organs. Dr. Jeffrey Cadeddu on the College of Texas Southwestern Medical Heart mixed the proprietary magnetic positioning system with Intuitive Surgical‘s Da Vinci SP (single-port) robotic. In the course of the process, the surgical group used the MARS platform to retract tissue inside the affected person exactly. This will increase visualization, permitting the group to protect nerves.
The Da Vinci SP supplied the capabilities required for this complicated urological surgical procedure. The Intuitive Surgical robotic makes an incision in order that surgeons can get contained in the affected person and carry out a process. The MARS system permits the surgeons better entry and visualization as soon as they’re contained in the physique, eradicating the boundaries that include single-port surgical procedure.
Editor’s Observe: This text was republished from sister web site MassDevice.
