Levita Magnetics' Magnetic Surgical System gains indication for bariatric and hiatal hernia repair procedures

Levita Magnetics has gained FDA clearance for the use of its Magnetic Surgical System (MSS), combined with the MARS system, in bariatric and hiatal hernia repair procedures. This expanded indication reinforces Levita's ability to support surgeons treating patients with obesity-related conditions, offering a less invasive solution that enables simultaneous treatment of hiatal hernias during bariatric surgery.

Levita 12.5mm Grasper

The FDA clearance enables clinicians to use the MARS system's Dynamic Magnetic Positioning technology to retract the liver and enhance visibility and access during hiatal hernia repairs. This approval offers an innovative, less invasive option for abdominal surgery and paves the way for broader adoption of the technology across hospitals and ambulatory surgical centres in the US.

The clearance also marks the release of Levita's new 12.5mm magnetic grasper, specifically engineered to improve visualisation and control in patients with high BMI and large or difficult-to-retract livers. The device allows surgeons to grasp the liver more centrally, rather than from the edge, improving surgical access in both hernia and bariatric procedures.

"This expanded clearance is a major step forward. With the improved grasper and magnetic liver retraction, I can now perform complex bariatric procedures and hiatal hernia repairs with greater visibility and fewer incisions," said Dr Chad Carlton, a Dallas-based surgeon and long-time MARS user. "It's a smarter, less invasive way to care for patients - especially those with high BMI and challenging anatomy, with less pain."

According to the company, unlike other robotic systems that often rely on rigid instrumentation and multiple incisions, the MARS platform introduces a new paradigm: using proprietary magnetic technology to reposition organs internally. This innovation allows surgeons to reduce the number of incisions, minimise tissue trauma, and enhance patient recovery, all while maintaining surgical precision and control.

"This milestone reinforces our commitment to expanding access to better surgery," said Dr Alberto Rodriguez-Navarro, founder and CEO of Levita Magnetics. "We're building a future where less invasive means more effective."