Dive Brief:
- Medtronic has received Food and Drug Administration clearance for a vessel-sealing technology used with its Hugo soft tissue robotic surgery system.
- The clearance, which Medtronic disclosed Wednesday, brings LigaSure technology, used in more than 45 million procedures worldwide, to the company’s robotic-assisted surgery platform.
- Targeting markets dominated by Intuitive, Medtronic has identified an opportunity to win share by pairing its platform with energy instruments that physicians use in non-robotic surgeries.
Dive Insight:
In June, Medtronic revealed it had filed for 510(k) clearance of its LigaSure RAS Maryland instrument on the Hugo platform. The filing was part of a set of submissions intended to grow the range of instruments cleared for use with Hugo and to expand use of the robotic platform into more indications. Medtronic disclosed the filings months after receiving FDA clearance for Hugo.
U.S. surgeons increasingly expect the same energy instruments in a robotic workflow as they rely on in open and laparoscopic settings, Medtronic said. The company framed the 510(k) clearance as a way to meet those expectations. Matthew Kroh, chief medical officer at Medtronic’s surgical business, explained the importance of vessel-sealing instruments to surgeons.
“Vessel sealing sits at the center of how surgeons work through the most demanding moments of a procedure, and surgeons have trusted LigaSure to do it across open and laparoscopic surgery for decades,” Kroh said in a statement. “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.”
The FDA clearance brings capabilities already available in Europe to the U.S. Medtronic received a CE mark for the robotic vessel-sealing technology in July 2025. Outside the U.S., Hugo has “positively impacted the lives of tens of thousands of patients across more than 35 countries,” Medtronic said.
With the robot now available in the U.S., Medtronic expects Hugo to pass 50,000 completed procedures this financial year, CEO Geoff Martha said on the company’s first-quarter earnings call this month. The company’s financial year ends in late April.
