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 mentioned the expanded indication reinforces its skill to help surgeons treating sufferers with obesity-related situations. It supplies a much less invasive resolution that allows simultaneous remedy of hiatal hernias throughout bariatric surgical procedure.
FDA clearance allows 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 affords an revolutionary, much less invasive possibility for stomach surgical procedure and paves the way in which for broader adoption of the expertise, Levita mentioned.
“This milestone reinforces our dedication to increasing entry to higher surgical procedure,” mentioned 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 huge or difficult-to-retract livers. The system permits surgeons to know the liver extra centrally, quite 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 allows full management throughout laparoscopic procedures.
Levita Magnetics’ MARS system makes use of magnetic forces to manage 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 business 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 received 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 inner organs. Dr. Jeffrey Cadeddu on the College of Texas Southwestern Medical Middle mixed the proprietary magnetic positioning system with Intuitive Surgical‘s Da Vinci SP (single-port) robotic. Through the process, the surgical workforce used the MARS platform to retract tissue throughout the affected person exactly. This will increase visualization, permitting the workforce to protect nerves.
The Da Vinci SP offered the capabilities required for this advanced 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 larger entry and visualization as soon as they’re contained in the physique, eradicating the boundaries that include single-port surgical procedure.
Editor’s Word: This text was republished from sister web site MassDevice.