Earlier this month, Medtronic announced that the U.S. Food and Drug Administration (FDA) has cleared its Hugo robotic-assisted surgery system for use in urologic surgical procedures.
With this clearance, Hugo can now be used for minimally invasive urologic procedures such as prostatectomy, nephrectomy, and cystectomy. These are common surgeries that, together, account for roughly 230,000 procedures each year in the United States.
“FDA clearance of the Hugo RAS system means there is now choice for hospitals looking to expand their robotic programs and increases access for patients,” said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic.
Read on to understand what this approval means and how the Hugo system works.
What does the FDA approval mean?
The FDA clearance allows Medtronic to begin a phased commercial rollout of the Hugo system in the U.S. It also positions Medtronic as a direct competitor to Intuitive Surgical’s da Vinci system, which has dominated the robotic surgery market for years.
The clearance was supported by data from the Expand URO clinical study, the largest multi-port robotic-assisted urology trial conducted in the U.S. The study showed that the Hugo system met its primary safety and effectiveness goals, with outcomes consistent with published clinical literature.
What is the Hugo Robotic System?
Hugo is Medtronic’s robotic platform designed for soft-tissue, minimally invasive surgery. Unlike traditional robotic systems that use a single large unit, Hugo features a modular design with independent robotic arms. These arms can be moved and positioned based on the needs of each procedure and operating room.
The system includes:
- Independent robotic arms that improve flexibility and reduce crowding in the operating room
- A surgeon console designed to improve comfort, visibility, and awareness
- Advanced instruments and 3D visualization to support precision during complex procedures
This modular approach allows hospitals to better use operating room space and potentially increase system utilization across different care settings.
Connected digital ecosystem
Hugo also integrates with Medtronic’s Touch Surgery ecosystem, which provides tools for pre-operative training, remote guidance, and post-operative performance insights. Surgeons can review case data and videos shortly after procedures, supporting learning and quality improvement.
Dr. James Porter, chief medical officer for Robotic Surgical Technologies at Medtronic, said the system offers a new approach to robotic surgery and supports teams throughout their robotic surgery journey.
Why this matters
Robotic-assisted surgery continues to grow in the U.S., but hospitals face challenges related to capacity, cost, and access. Medtronic has positioned Hugo as a more flexible and potentially more cost-efficient option, especially for mid-sized hospitals and community health systems that have struggled to adopt robotics.
Outside the U.S., the Hugo system has already been used in tens of thousands of procedures across more than 30 countries, including urologic, gynecologic, and general surgeries.
As more hospitals look to expand minimally invasive care, the FDA clearance of the Hugo system brings greater choice into a market long dominated by a single platform.
-Rinkle Dudhani and the AHT Team
