FDA clears Medtronic's Hugo surgical robot for urologic procedures
On December 3, 2025, Medtronic announced FDA clearance of its Hugo robotic-assisted surgery system for prostatectomy, nephrectomy and cystectomy. The company says these procedures account for about 230,000 US surgeries a year. The clearance was based on the Expand URO study, which Medtronic says met its primary safety and effectiveness endpoints. Hugo was already in use in more than 30 countries, and Medtronic says it expects general and gynecologic surgery indications to follow.
Why it's notable: Hugo is the first multi-port system from a large medtech company to enter the US soft-tissue robotics market dominated by Intuitive's da Vinci. That gives hospitals building robotic urology programs a second option from a major vendor.