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Home » FDA clears Levita’s Magnetic Surgical System for pediatric use; Cleveland Clinic Children’s performs first US surgery

FDA clears Levita’s Magnetic Surgical System for pediatric use; Cleveland Clinic Children’s performs first US surgery

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A photo of surgeons using Levita Magnetics surgical robot at Cleveland Clinic Children’s.
Cleveland Clinic Children’s surgeons used the Levita Magnetics MSS and MARS systems for the first time for a pediatric laparoscopic cholecystectomy. [Photo courtesy of Cleveland Clinic Children’s]
Levita Magnetics has received FDA 510(k) clearance for its Magnetic Surgical System (MSS) to be used in certain pediatric surgeries, with the first U.S. surgery performed at Cleveland Clinic Children’s earlier this month.

The latest MSS clearance is for laparoscopic cholecystectomies in pediatric patients ages 12 and older within a BMI range of 20-34 kg/m².

“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.

Dr. Miguel Guelfand used Levita’s magnetic and robotic surgical technology to gently move the patient’s gallbladder for better visualization of the surrounding tissue while performing the laparoscopic procedure. “Without the magnetic tool, an additional incision would have been needed so that a surgical assistant could hold the gallbladder in place with a laparoscopic instrument,” Cleveland Clinic Children’s said.[Photo courtesy of Cleveland Clinic Children’s]
Guelfand was part of the team that conducted that first pediatric cholecystectomy using MSS with Levita’s MARS (magnetic-assisted robotic surgery) system on Nov. 6.

“This case represents a major step forward in our ongoing mission to advance minimally invasive and robotic surgery in neonates and children,” Guelfand said on LinkedIn after the first surgery. “The MARS system combines the advantages of magnetic retraction with robotic control, allowing greater visualization and dexterity through less incisions — a true paradigm shift for pediatric patients. … This is only the beginning — and a glimpse into the future of pediatric MIS and robotic surgery.”

Mountain View, California–based Levita launched MSS in 2016. MSS is comprised of a laparoscopic magnetic grasper, a grasper tip that attaches to tissue inside the body, and an external magnetic controller that attracts the grasper tip to manipulate the attached tissue.

Levita Magnetics' Magnetic Surgical System
The Levita Magnetics Magnetic Surgical System (MSS) uses a magnet outside of the body to eliminate one of the incisions in high-volume abdominal procedures. [Image courtesy of Levita Magnetics]
The MSS magnetic controller can be attached to the robotic arm on Levita’s MARS system, which won FDA 510(k) clearance in 2023 and was soon after used for the first time commercially at the Cleveland Clinic. That system uses magnets and robotics to reduce the number of incisions required in laparoscopic procedures and give surgeons even more control when using MSS.

The latest MSS clearance “marks a defining moment for the future of surgery,” Levita Magnetics founder, CEO and President Dr. Alberto Rodriguez-Navarro said in a statement shared with MassDevice ahead of the announcement.

A photo of a surgeon using the Levita Magnetics MARS (magnetic-assisted robotic surgery) system.
The Levita Magnetics MARS (magnetic-assisted robotic surgery) system uses magnetic forces to control a grasper instrument inside a patient. [Image courtesy 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,” he said. “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.”

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In September, Levita announced the world’s first gall bladder surgery using an autonomous surgical camera and in recent years has been researching the use of its technology with artificial intelligence, augmented reality and even other surgical robotics systems.

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About Jim Hammerand

Jim Hammerand is the managing editor of Arrowfly's MassDevice and Medical Design & Outsourcing, where he leads coverage of medtech innovation, design, engineering and manufacturing. He also contributes to our Devicetalks podcasts and live events. Hammerand has more than two decades of journalism experience spanning newspapers, magazines, websites, live events, radio and TV news. For nearly a decade, Hammerand reported and edited business news for American City Business Journals as a reporter and digital editor at the Minneapolis/St. Paul Business Journal and then as managing editor of the Puget Sound Business Journal in Seattle. He holds degrees in journalism and management from the University of Minnesota and has won journalism awards from the Society of Professional Journalists, American Society of Business Publication Editors, and Trade, Association, Business Publications International. Connect with him on LinkedIn or by email at [email protected].