Medtronic to expand Hugo robotic surgery system into general and gynecologic procedures in the U.S.

Medtronic has submitted two 510(k) applications to the U.S. Food and Drug Administration (FDA) aimed at expanding the use of its Hugo™ robotic-assisted surgery (RAS) system into general surgery and gynecologic procedures, marking the company’s latest step in broadening its presence in the surgical robotics market.

Expanding Hugo’s clinical footprint in the U.S.

The submissions come just months after the Hugo system received FDA clearance for urologic procedures in the United States, a milestone that enabled Medtronic to begin commercial adoption of the platform in the country’s robotic surgery market.

If cleared, the new indications would significantly increase the clinical applications of the Hugo platform in the U.S., allowing surgeons to use the system across some of the highest-volume minimally invasive surgical specialties. General surgery applications would include procedures such as hernia repair, while the gynecology indication would support a range of hysterectomy procedures.

The company also announced additional regulatory and product developments designed to strengthen its surgical portfolio. Medtronic has submitted a 510(k) application for its LigaSure™ RAS Maryland instrument for use with the Hugo system and has received FDA clearance for its ProGrip™ Advanced self-gripping polypropylene mesh for robotic-assisted ventral hernia repair procedures.

According to Medtronic, these milestones are intended to create a more integrated robotic surgery ecosystem by combining robotic technology, advanced surgical instruments and procedural solutions within a single platform.

Building a broader robotic surgery ecosystem

The latest submissions build on the company’s ongoing clinical efforts in gynecology. In October 2025, Medtronic launched its Embrace Gynecology investigational device exemption (IDE) study to evaluate the safety and effectiveness of the Hugo system in hysterectomy procedures. The company has now completed patient enrollment in the study, supporting its regulatory submission for gynecologic use.

Outside the United States, the Hugo platform has already been used in tens of thousands of procedures across more than 35 countries and multiple specialties, including urology, gynecology and general surgery. This international experience has helped generate clinical evidence and operational insights as Medtronic works to expand adoption of the system globally.

The move also highlights the increasing competition within the robotic-assisted surgery market. Medtronic is positioning Hugo as an alternative to established systems while seeking to expand access to minimally invasive procedures through a broader portfolio of robotic technologies and surgical tools. Industry observers view the company’s latest regulatory filings as an important step toward increasing its footprint in a market that continues to attract significant investment and innovation.

The Hugo system features an open-console design intended to enhance collaboration and situational awareness in the operating room. Medtronic has said the platform is designed to support a connected surgical environment that combines robotics, data and instrumentation to assist surgeons during complex procedures.

The FDA’s review of the new 510(k) submissions will determine whether the Hugo robotic-assisted surgery system can move beyond its current urology indication and into the broader general surgery and gynecology markets in the United States, potentially opening a substantial new growth opportunity for Medtronic’s surgical business.

Source

Medtronic

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