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Levita’s Magnetic Surgical System Wins FDA Nod for Pediatrics

In addition, surgeons at Cleveland Clinic Children’s completed the first pediatric procedure in the U.S. using Levita’s MARS system.

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By: Sam Brusco

Associate Editor

Dr. Miguel Guelfand, professor and head of pediatric general and thoracic surgery at Cleveland Clinic Children's, performs a pediatric laparoscopic cholecystectomy using the MARS System in combination with the FDA-cleared Magnetic Surgical System (MSS). Photo: Levita Magnetics

Levita Magnetics has earned U.S. Food and Drug Administration (FDA) clearance for its Magnetic Surgical System (MSS) for pediatric patients. In addition, surgeons at Cleveland Clinic Children’s completed the first pediatric procedure in the U.S. using Levita’s MARS system along with the FDA-cleared MSS for laparoscopic cholecystectomy.

The company’s technology leverages external magnets to control internal instruments. This reduces the number of incisions usually needed for laparoscopic surgeries.

The MARS system merges advanced surgical precision with Levita’s Dynamic Magnetic Positioning technology to reduce the number of incisions. It magnetically retracts organs and soft tissues, rather than additional fixed ports—the system boosts visualization and control while reducing surgical trauma, the company said.

“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.”

MARS, when used with the MSS, is now FDA-cleared for adult and adolescent gallbladder, bariatric, prostate, colorectal, and hiatal hernia procedures.

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