Home » Medtronic Wins FDA Clearance for LigaSure Device on Hugo Robot

Medtronic Wins FDA Clearance for LigaSure Device on Hugo Robot

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Surgical Robot In Operating Room

A surgeon at the console wants to know one thing about a new tool: will it behave the way the old one did? On September 16, 2026, Medtronic said the U.S. Food and Drug Administration had cleared an instrument aimed at that question, the LigaSure RAS Maryland jaw device, for use with the company’s Hugo robotic-assisted surgery system.

Medtronic calls it the first robotically driven LigaSure instrument. It works only with the Valleylab FT10 energy platform on Hugo. The company says it seals and cuts vessels, thick tissue and lymphatics up to and including 7 mm in diameter, seals vessels in about 2 seconds, and limits thermal spread to the tissue around them. For patients, less heat reaching surrounding tissue is the point of the design.

The underlying vessel-sealing technology is not new. Medtronic says it has been used in more than 45 million procedures in over 65 countries across the past two decades, and that the robotic version reached Hugo in Europe in 2025 after CE Mark. The U.S. clearance covers a filing the company had made earlier, which was still pending when it announced other submissions on June 3, 2026.

“Bringing that same performance to the Hugo RAS system in the U.S. means surgeons carry the confidence and control they already rely on into their robotic-assisted cases,” said Dr. Matthew Kroh, chief medical officer within Medtronic’s Surgical business and a practicing surgeon. He noted that surgeons have trusted LigaSure in open and laparoscopic surgery for decades.

Where Hugo stands

In the United States, Hugo is cleared only for urologic procedures. Medtronic received that clearance in December 2025, and the system is now in use at a growing number of hospitals and health systems. Abroad it has a longer record: tens of thousands of patients in more than 35 countries, across more than 50 procedures in urology, general surgery and gynecology.

The company wants the same range at home. In June it filed 510(k) applications for general surgery, including hernia repair, and for gynecologic surgery. It also said it had finished enrolling its Embrace Gynecology study, which followed 70 patients at 5 U.S. hospitals. Those decisions are still to come, and Medtronic gave no date for either them or the commercial launch of the new instrument. Anyone weighing a robotic operation should talk it through with their own surgeon, and consult your doctor for medical advice.

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