Hugo RAS received FDA clearance in December 2025, bringing robotic surgery options to US hospitals after proven use in 30+ countries.
Photo source:
medtronic.com
In the United States, robotic-assisted surgery
has become the standard for many procedures. Approximately 80 percent of
urologic abdominal surgeries in the US today are performed with robotic
assistance. Yet many hospitals struggle with limited robotic capacity, long
surgery schedules, and equipment costs that prevent smaller and rural hospitals
from offering these procedures to their patients. Surgeons and hospital
administrators face real constraints: Do we invest in robotic surgery? Can we
afford it? Will we have adequate training support? Can we manage multiple
systems efficiently? These questions have kept minimally invasive robotic
surgery concentrated in large academic medical centers. Medtronic's Hugo
robotic-assisted surgery system offers US hospitals a new option. The system
received FDA clearance on December 3, 2025, for use in urologic surgical
procedures. Dr. Jihad Kaouk at the Cleveland Clinic performed the first US
commercial case in February 2026, a robotic-assisted prostatectomy where the
patient was discharged the following day.
The Hugo RAS system is designed specifically
for hospital operating rooms and surgeon collaboration. Unlike some competitor
systems, Hugo features an open console that keeps the surgeon connected
visually and physically to the bedside team. This design supports real-time
communication and collaborative training in the operating room. Surgeons can
see and speak with nurses and assistants without losing focus on the procedure.
The system also uses modular arm carts that can be positioned flexibly for different
procedures. Surgeons use only the number of arms they need for each case,
reducing setup time and the number of disposable instruments required. This
efficiency matters for hospitals managing multiple daily surgeries. The system
integrates with the Touch Surgery ecosystem, which provides preoperative
training tools, remote tele-proctoring capabilities, and AI-powered
post-operative insights. Surgeons can review case videos and performance
analytics minutes after completing a procedure, supporting continuous
improvement and knowledge sharing among surgical teams.
Hugo's FDA clearance in the US follows years of
real-world hospital experience globally. The system has been used in over 30
countries on five continents. Healthcare systems in Korea, Europe, the Middle
East, Asia, and other regions have completed tens of thousands of urologic,
gynecologic, and general surgery procedures. This global experience provides
evidence of safety and effectiveness. Nearly 250 academic papers have been
published documenting outcomes, techniques, and applications. Hospitals in South
Korea approved Hugo in 2024 and have already expanded its use to diverse
surgical specialties. This international track record demonstrates that Hugo
can function effectively in varied healthcare settings with different patient
populations and surgical traditions.
For US healthcare, Hugo represents choice and
opportunity. Large academic centers can expand their robotic programs.
Community hospitals can invest in robotic surgery capacity without the expense
and complexity of alternative systems. Rural hospitals and smaller facilities
gain pathways to offer minimally invasive procedures locally. Patients benefit
from faster recovery times, reduced blood loss, and minimal scarring compared
to open surgery. They can receive advanced surgical care closer to home rather
than traveling to distant academic centers. Medtronic intends to expand Hugo's
US use to gynecologic and general surgical procedures in the coming years, further
broadening its applications in healthcare settings.
Please subscribe to have unlimited access to our innovations.