Medtronic has secured U.S. Food and Drug Administration 510(k) clearance for LigaSure RAS Maryland, the first robotic-driven version of its widely used vessel-sealing platform, for use on the Hugo robotic-assisted surgery system in the United States.
Robotic LigaSure Comes To Hugo
The Maryland-jaw device, cleared on September 16, 2026, is designed exclusively for Hugo and pairs with Medtronic's Valleylab FT10 energy platform. It can seal and cut vessels, thick tissue and lymphatics up to 7mm in roughly two seconds, with the low thermal spread that has made LigaSure a workhorse instrument for more than two decades and 45 million-plus procedures across open and laparoscopic settings.
Filling A Missing Piece Of The Hugo Portfolio
"Surgeons increasingly expect the same trusted energy instruments in a robotic workflow that they rely on in open and laparoscopic settings," Medtronic said in the clearance announcement, framing the Maryland device as a portfolio gap-filler. Dr. Matthew Kroh, chief medical officer of Medtronic's surgical business, described vessel sealing as sitting "at the center of how surgeons work through the most demanding moments of a procedure." The instrument had already been introduced in Europe in 2025 following CE Mark; the U.S. clearance ends a nearly year-long delta between the two markets.
Where Hugo Sits In The U.S. Market
Hugo is currently cleared in the U.S. for urologic procedures, with Medtronic having submitted 510(k) filings for general and gynecologic surgery earlier this year. The company says Hugo is now in commercial use at a growing number of leading U.S. health systems and hospitals, and is used across more than 50 procedures in 35+ countries. The LigaSure clearance strengthens that beachhead by giving U.S. Hugo surgeons a robotic-native energy device that matches what they use in their open cases.
Competitive Backdrop
Medtronic's push comes as Intuitive Surgical's da Vinci franchise still dominates global robotic-assisted surgery, but with Johnson & Johnson's Ottava and CMR Surgical's Versius Plus rapidly building U.S. footprints. Broadening the Hugo instrument portfolio, on top of Medtronic's recent $700 million partnership with Cornerstone Robotics and its Touch Surgery Aide real-time AI platform, is central to Medtronic's plan to offer hospitals a two-platform, AI-augmented robotic-surgery stack.
Reporting based on coverage from Medtronic's newsroom, Ortho Spine News and MedTech Dive.