Medtronic, which is a global leader when it comes to surgical innovation, announced on December 3, 2025, that the U.S. Food and Drug Administration – FDA has gone ahead and cleared the Hugoâ„¢ robotic-assisted surgery – RAS system so as to use in urologic surgical procedures. The clearance to Hugo RAS system goes on to bring a very versatile robotic-assisted platform to the U.S. surgeons as well as health systems that are looking to expand the soft-tissue robotic surgery programs and access the minimally invasive care.
It is well to be noted that the U.S. leads the world when it comes to robotic surgery adoption; still, hospitals consistently face issues in terms of capacity as well as access.
The advent and clearance to Hugo RAS system in the U.S. enables us to address this gap, thereby offering an innovative approach to robotic-assisted surgery from the worldwide leader in surgery and bringing options to hospitals along with surgeons throughout the country.
According to Rajit Kamal, the vice president and general manager of Robotic Surgical Technologies in the surgical business of Medtronic, this is indeed an incredibly exciting day as far as healthcare in the United States is concerned. The clearance of the Hugo RAS system by the FDA means that there is now an option for hospitals that are looking to expand their robotic programs, and it also increases access for patients. He added that as the purposeful launch of the Hugo RAS system in the U.S. starts, their focus is on building a robust foundation along with leading hospitals by way of their differentiated approach to partnership, rooted in their consistent commitment to offering an excellent customer experience and at the same time enabling the surgical teams to roll out the best possible outcomes when it comes to their patients.
Thoughtfully designed with inputs coming from surgeons as well as hospital administrators to shape the future of surgery, the Hugo RAS system has three main differentiators –
Modular Design – The innovative modular design of the Hugo RAS system goes on to mean that the robotic arms can be moved, be shared, and get deployed easily throughout any care setting, therefore helping to maximize the utilization and offering surgeons the agility to tailor-make their approach so as to optimize the anatomical access for the unique needs that address every patient. Notably, the open design of the surgeon console offers greater situational awareness as well as visualization, decreases the physical strain, and also creates elevated training opportunities for the surgical teams, hence helping with better bedside communication along with team integration.
Digital Ecosystem – The Hugo RAS system connects easily with the Touch Surgeryâ„¢ ecosystem, which offers preoperative training tools, remote tele-proctoring capacities, and also AI-powered postoperative case insights. Surgeons may go ahead and securely access case videos seconds after a procedure gets completed, therefore supporting consistent enhancement as well as partnership among the hospital teams and also with their peers throughout the global surgical community.
Differentiated Partnership – Medtronic apparently is the first and only company that can meet the surgeon requirements throughout all surgical modalities, be they open, laparoscopic, or robotic-assisted. The addition of the Hugo RAS system offers surgical teams access to world-class robotic training along with deep clinical as well as technical expertise and also serves as an option when determining the ideal surgical approach for every patient’s unique requirement, with the opportunity to make use of the trusted Medtronic technologies as well as instruments as the technology thrives.
Notably, the Hugo RAS system goes on to represent a new as well as exciting approach to robotic-assisted surgery, opines Dr. James Porter, who is a urologic surgeon as well as the chief medical officer for Robotic Surgical Technologies along with Digital Technologies in the Surgical business at Medtronic. He added that they are indeed quite excited for surgical teams across the U.S. to go ahead and experience the differentiated technology as well as the partnership from Medtronic, which, by the way, supports them at every stage when it comes to their robotic surgical journey.
Due to the FDA clearance, the Hugo RAS system is going to be indicated for usage in minimally invasive urologic surgical procedures that include the likes of nephrectomy and prostatectomy.
as well as cystectomy, which are all common procedures accounting for almost 230,000 surgeries every year in the U.S.
Interestingly, the Expand URO investigational device exemption clinical study, which, by the way, is the largest ever completed for multi-port robotic-assisted surgery in the U.S., went on to demonstrate that the Hugo RAS system did meet the primary safety as well as effectiveness endpoints within urologic surgical procedures, with outcomes that were pretty consistent with the published literature.
Outside of the U.S., the Hugo RAS system is being used across tens of thousands of urologic and gynecologic as well as general surgery procedures in over 30 countries throughout 5 continents. Medtronic looks forward to expanding the use of the Hugo RAS system in the U.S. to certain more surgical specialties with time, with indications for general as well as gynecologic surgical procedures anticipated to follow the initial urology clearance.
The fact is that the introduction of the Hugo RAS system in the U.S. builds on the broad surgical offering by Medtronic, which includes the Touch Surgery ecosystem, in order to deliver a connected as well as an integrated operating room today and also in the future.