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.
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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.
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.
“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.”
