FDA clears Levita’s System

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

November 18, 2025
9:27 pm

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.

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.

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

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