Medtronic’s Hugo RAS System Wins FDA Approval 

The U.S. Food and Drug Administration has cleared Medtronic’s Hugo robotic-assisted surgery system for urologic surgical procedures.  

The clearance marks Hugo’s official entry into the U.S. market, where roughly 230,000 urologic surgeries—including prostate, kidney and bladder operations—are performed annually. 

Hospitals across the country have faced growing demand for robotic-assisted surgery, but access to established platforms has been limited.  

Medtronic executives say the system’s design and digital ecosystem could help hospitals effectively expand robotic programs.  

“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,” Medtronic vice president and general manager of robotic surgical technologies Rajit Kamal said.  

“As we begin our purposeful launch of the Hugo RAS system in the U.S., our focus is on building a strong foundation with leading hospitals through our differentiated approach to partnership.” 

Expanding Access

Medtronic officials said Hugo’s open console design aims to reduce surgeon fatigue and improve communication with bedside teams. 

The robotic arms can be moved and shared across operating rooms, which gives hospitals flexibility to tailor setups for different cases.  

The system also connects to Medtronic’s touch surgery platform, which offers AI-powered case analytics and remote tele-proctoring.  

The system also connects to Medtronic’s touch surgery platform, which offers AI-powered case analytics.  

FDA clearance comes after an in-depth study confirmed Hugo’s safety and effectiveness for urologic procedures.  

The system has already been used in tens of thousands of surgeries across more than 30 countries.  

Medtronic officials said the company intends to expand the system’s use in the U.S. to additional surgical specialties in the future.