Levita's Magnetic Surgical System Achieves FDA Clearance for Pediatric Use; Cleveland Clinic Children's Performs First Case with MARS System

Milestone procedure marks the first U.S. pediatric use of magnetic-assisted surgical technology, expanding its indication following FDA clearance.

MOUNTAIN VIEW, Calif., Nov. 18, 2025 /PRNewswire/ -- Levita® Magnetics, a leader in advanced surgical technology and the first company to offer magnetic assistance in minimally invasive surgery, today announced a major milestone: FDA clearance of its Magnetic Surgical System (MSS) for pediatric patients.¹ Surgeons at Cleveland Clinic Children's have successfully completed the first pediatric procedure in the United States using Levita's MARS® System in combination with the FDA-cleared MSS for laparoscopic cholecystectomy.

The technology uses external magnets to control internal surgical instruments, reducing the number of incisions typically required in laparoscopic procedures.

"For pediatric patients, minimizing surgical trauma is critical—less pain, faster recovery, and fewer scars all contribute to better long-term physical and emotional outcomes," said Dr. Miguel Guelfand, professor and head of pediatric general and thoracic surgery at Cleveland Clinic Children's.

The MARS System combines advanced surgical precision with Levita's proprietary Dynamic Magnetic Positioning® technology to reduce the number of incisions in laparoscopic procedures. By using magnetic retraction of organs and soft tissue—rather than additional fixed ports—the system enhances visualization and control while significantly reducing surgical trauma.

"This clearance marks a defining moment for the future of surgery," said Dr. Alberto Rodriguez-Navarro, surgeon and CEO of Levita Magnetics. "By expanding magnetic-assisted, minimally invasive surgery to children, we're setting a new standard in safety and recovery—reducing trauma, accelerating healing, and improving quality of life for patients and families. This is not just technological progress; it's progress in compassion. Our vision is a future where every patient, regardless of age, benefits from safer, more intelligent, and truly human-centered surgical care."

This milestone reinforces Levita Magnetics' leadership in surgical innovation and builds on its track record of clinical firsts across the U.S. and Latin America. It marks a major advancement in pediatric care and underscores the company's commitment to developing technologies that deliver meaningful benefits for patients and families.

About Levita Magnetics

Levita Magnetics is a Silicon Valley-based medical technology company, pioneering minimally invasive platforms that use magnetics to improve precision while reducing invasiveness. Its flagship MARS system provides surgeons enhanced control and visualization while minimizing trauma from traditional surgery. MARS, when used with Levita's Magnetic Surgical System (MSS), is FDA-cleared for adult and adolescent gallbladder, bariatric, prostate, colorectal, and hiatal hernia procedures. Together, MARS and MSS enable less invasive, controlled abdominal surgeries by combining Dynamic Magnetic Positioning with advanced instrumentation. Learn more at levita.com.

¹ The Magnetic Surgical System is now cleared by the FDA for use in laparoscopic cholecystectomy procedures in pediatric patients ages 12 and older within a BMI range of 20 to 34kgm², expanding its indication beyond adult surgery and paving the way for nationwide adoption of magnetic-assisted surgery in pediatric care.

Media Contact:
Tim Gray
917.202.9515
[email protected]

MKT2542.A

SOURCE Levita Magnetics