Business
Medtronic submits 510(k) filings to expand Hugo™ robotic-assisted surgery system into general and gynecologic specialties in the United States
Medtronic (NYSE: MDT), a global leader in healthcare technology, today 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.
About this update from Medtronic Plc.
Company also announces 510(k) pending for LigaSure™ RAS Maryland instrument on the Hugo RAS system, and 510(k) clearance for ProGrip™ Advanced self-gripping polypropylene mesh for use in robotic-assisted ventral hernia repair surgeries GALWAY, Ireland, June 3, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today 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. 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. Medtronic is the first and only company that can meet surgeons' needs across all surgical modalities — open, laparoscopic, and robotic-assisted — giving surgeons and health systems the choice and partnership required to build and grow successful surgery programs across care settings. "These milestones and innovative technologies will unlock our ability to enhance the value of our partnership in general and gynecologic surgical procedures," said Matt Anderson, senior vice president and president of the Surgical business at Medtronic. "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. One that enables every patient, everywhere, access to the best possible surgery." Expanding Hugo™ RAS indications and capabilitiesThe 510(k) filings for Hugo RAS system use in general surgery and gynecological procedures would significantly broaden the platform's clinical applicability in the U.S. 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 gynecologic surgery to advance patient care globally; they are also indications where the Hugo RAS...