Levita Magnetics wins de novo FDA clearance for gallbladder surgery device

Medical device developer Levita Magnetics said today it won FDA de novo clearance for its magnetic surgical system with indications for gallbladder removal surgery, and launched the system in the U.S.

The system is designed to retract and maneuver the gallbladder using magnetic fields, which the San Mateo, Calif.-based company said “reduces the number of incisions” necessary for the procedure and prevents damage to the abdominal wall.

“We are proud to be the pioneers of magnetic surgery. Having been a minimally invasive surgeon for over 10 years, I understand the complexity my peers face when trying to gain proper access to organs. Our goal at Levita is to equip surgeons with the technology they need to make surgery easier and less invasive, while enabling improved patient outcomes,” CEO Dr. Alberto Rodriguez-Navarro said in a press release.

The company said that the FDA created a new category to accommodate the unique magnetic surgery platform, and said the platform also recently won CE Mark approval in the European Union.

“We are at the beginning of an exciting advance in surgery and I look forward to using magnetic surgery to help my patients,” Dr. Matthew Kroh of the Cleveland Clinic, the 1st to use the system, said in a prepared statement.

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