Medtronic submits 510(k) filings to expand Hugo robotic-assisted surgery

Medtronic has announced significant milestones to unlock expanded indications for the Hugo robotic-assisted surgery (RAS) system in the US. The company has submitted 510(k) clearance for gynaecological surgery, general surgery indication including hernia repair, the LigaSure RAS Maryland instrument and for the ProGrip Advanced mesh for use in robotic-assisted ventral hernia repair.

These milestones build momentum for Medtronic's Surgical business and its purposeful launch of the Hugo RAS system, which received FDA clearance for urologic surgical procedures in December 2025 and is in commercial use at leading U.S. medical centres. With nearly five years of commercial experience across more than 35 countries in five continents, the Hugo RAS system has been used in tens of thousands of procedures and its safety and effectiveness is supported by hundreds of independently published scientific papers.

"This isn't just a portfolio expansion, it's part of our ongoing commitment to unite instruments, intelligence, and human hands into one unique surgical ecosystem,” said Matt Anderson, senior vice president and president of the Surgical business at Medtronic. “One that enables every patient, everywhere, access to the best possible surgery."

The 510(k) filings for Hugo RAS system use in general surgery and gynaecological procedures would significantly broaden the platform's clinical applicability in the US and address growing demand for robotic-assisted minimally invasive options in these high-volume specialties. Medtronic has decades of experience collaborating with surgical teams in general surgery and gynaecologic surgery to advance patient care globally; they are also indications where the Hugo RAS system is in clinical use in major markets outside the US.

Bringing together technology surgeons trust and furthering its commitment to continually enhancing Hugo RAS system capabilities, Medtronic announced it has submitted a 510(k) filing to the FDA for the LigaSure RAS Maryland instrument. Designed exclusively for use with the Valleylab FT10 energy platform on the Hugo™ RAS system, LigaSure RAS incorporates vessel-sealing technology that has been used in more than 35 million procedures across 65+ countries. LigaSure RAS was introduced on the Hugo RAS system in Europe in 2025.

"LigaSure technology has been transformative for surgery and integrating it onto the Hugo RAS system gives surgeons greater confidence and control during critical moments in complex procedures," said Dr Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing general surgeon. "As more and more surgeons and patients demand robotic-assisted surgery, we need more access to technology and training, and Medtronic brings that choice in a very powerful way."

Medtronic received FDA clearance for ProGrip Advanced, an evolution of existing mesh technologies to better align with the specific demands of robotic-assisted ventral hernia repair.

ProGrip meshes have been used in more than 6 million procedures. According to Medtronic ProGrip Advanced supports surgical efficiency in robotic procedures by making it easier to introduce through trocars, handle, deploy, and unfold compared to previously available products and comes in a variety of sizes to meet each patient's needs.

Every year, nearly 470,000 ventral hernia repair procedures are performed in the US more and more are being done with the assistance of a robot, and an increasing number are performed at alternative sites of care as hospitals shift lower acuity procedures to ambulatory centres to support a patient-centred approach to care while managing cost pressures and capacity challenges.