Medtronic has filed two 510(k) clearance applications with the FDA to expand its Hugo robotic-assisted surgery (RAS) system into US general surgery, including hernia repair, and gynecologic procedures, marking the platform's biggest US indication push since its urology clearance in December 2025.
Two new specialties on the table
The general-surgery and gynecology filings, both submitted in early June 2026, would significantly broaden Hugo's addressable market in the US and target two of the highest-volume robotic-assisted minimally invasive specialties. Hugo is already in clinical use in those indications across more than 35 countries on five continents, with what Medtronic says is "tens of thousands of procedures" and hundreds of independently published scientific papers backing its safety and effectiveness.
Embrace Gynecology IDE closes enrollment
Alongside the filings, Medtronic announced it has completed enrollment in the Embrace Gynecology IDE clinical study, a 70-patient, five-site US prospective multicentre trial designed to support the gynecologic 510(k) submission. Matt Anderson, senior vice president and president of Medtronic's Surgical business, called the announcement "part of our ongoing commitment to unite instruments, intelligence, and human hands into one unique surgical ecosystem."
LigaSure RAS and ProGrip Advanced round out the launch
Medtronic also submitted a 510(k) for the LigaSure RAS Maryland instrument on the Valleylab FT10 platform, extending the vessel-sealing technology that has been used in 35 million procedures across 65+ countries. Separately, the company received FDA clearance for ProGrip Advanced, a self-gripping polypropylene mesh designed specifically for robotic-assisted ventral hernia repair. With 470,000 ventral hernia repairs done each year in the US and an increasing share performed robotically and at ambulatory sites, Medtronic frames the launch as filling a clear procedural gap.
The expansion arrives as competitors push next-generation platforms, including CMR Surgical's Versius Plus US cholecystectomy clearance and its parallel gynecology filing, alongside J&J's Ottava gastric bypass data.
Reporting based on coverage from Medtronic and Surgical Robotics Technology.