FDA Expands Indication for Levita Magnetics' Magnetic Surgical System with MARS® for Minimally Invasive Bariatric and Hiatal Hernia Repair

New clearance expands clinical use of the disruptive Dynamic Magnetic Positioning™ technology for liver retraction in bariatric and hiatal hernia procedures, improving outcomes in complex cases with fewer incisions

MOUNTAIN VIEW, Calif., June 18, 2025 /PRNewswire/ -- Levita Magnetics, a company in the forefront of surgical innovation, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of its Magnetic Surgical System (MSS), combined with the MARS® system's, 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.

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 centers nationwide. The clearance also marks the release of Levita's new 12.5mm magnetic grasper, specifically engineered to improve visualization 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."

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, minimize 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."

Commercial Momentum and Market Opportunity

Hiatal hernia repair is a common procedure, frequently performed alongside bariatric surgery in patients with obesity-related conditions. Levita's newly cleared indication allows the MARS system to better support this high-need patient population, offering improved access and visualization through magnetic retraction and an updated toolset.

With the addition of this indication and the new 12.5mm grasper, Levita is expanding its addressable market and strengthening its commercial offerings for surgical teams managing complex abdominal cases.

Pioneering the Future of Magnetically Assisted Surgeries

Levita's continued innovation has opened new frontiers in surgical care. From enabling groundbreaking bariatric procedures to supporting surgeries designed to improve quality of life, the company's MARS platform is redefining what's possible in the operating room. With a growing body of clinical use cases and national media attention highlighting patient outcomes—from dramatic weight loss to minimally invasive cancer-related procedures, Levita is helping surgeons deliver transformative results across a wide spectrum of care.

Levita also continues to expand its clinical presence nationwide and internationally and expects to install systems at multiple top-tier institutions in the short term.

For media inquiries or to request an interview with Dr. Carlton or Dr. Rodriguez-Navarro, please contact:

Tim Gray
Communications Strategist
917-202-9515
396881@email4pr.com

About Levita Magnetics
Levita Magnetics is a Silicon Valley-based medical device company pioneering --minimally invasive platforms that use magnetics to improve surgical precision while reducing invasiveness. Its flagship MARS system provides surgeons with enhanced control and visualization while minimizing the trauma of traditional surgery. The MARS platform is FDA-approved for gallbladder, bariatric, prostate, colorectal, and now hiatal hernia procedures.

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SOURCE Levita Magnetics