June 3, 2026- Medtronic announced significant milestones to unlock expanded indications for the Hugo™ robotic-assisted surgery (RAS) system in the United States and to shape the future of surgery.
- General surgery indication including hernia repair — 510(k) clearance submitted
- Embrace Gynecology Investigational Device Exemption (IDE) clinical study — completed enrollment
- Gynecologic surgery indication — 510(k) clearance submitted
- LigaSure™ RAS Maryland instrument — 510(k) clearance submitted
- ProGrip™ Advanced mesh for use in robotic-assisted ventral hernia repair — 510(k) clearance received
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 centers. 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.