Medtronic has received clearance from the U.S. Food and Drug Administration (FDA) for its Hugo robotic-assisted surgery (RAS) system, which will now be available for urologic surgical procedures in the United States. The company announced that this development introduces a new option for hospitals and surgeons seeking to expand their use of minimally invasive soft-tissue robotic surgery.
The United States currently leads globally in the adoption of robotic surgery, but hospitals often encounter challenges related to capacity and access. Medtronic aims to address these issues with the introduction of the Hugo RAS system, providing what it describes as a versatile and innovative platform for healthcare providers across the country.
“This is an incredibly exciting day for healthcare 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 Medtronic’s Surgical business. “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, rooted in our enduring commitment to provide an excellent customer experience and enable surgical teams to deliver the best possible outcomes for their patients.”
The Hugo RAS system features several design elements developed with input from both surgeons and hospital administrators. These include a modular design allowing flexible use of robotic arms across different care settings, integration with Medtronic’s Touch Surgery digital ecosystem for training and postoperative analysis, and what Medtronic describes as a differentiated partnership model supporting various surgical modalities—open, laparoscopic, or robotic-assisted.
“The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery,” said Dr. James Porter, chief medical officer for Robotic Surgical Technologies and Digital Technologies at Medtronic. “We’re excited for surgical teams in the U.S. to experience the differentiated technology and partnership from Medtronic, which supports them at every stage of their robotic surgical journey.”
With FDA clearance now secured, the Hugo RAS system is approved for minimally invasive urologic surgeries such as prostatectomy, nephrectomy, and cystectomy—procedures accounting for approximately 230,000 surgeries annually in the U.S.
Medtronic highlighted that results from its Expand URO clinical study—the largest multi-port robotic-assisted urological surgery trial conducted in the U.S.—showed that safety and effectiveness endpoints were met using this technology.
Globally, outside of the United States, Medtronic reports that its Hugo RAS system has already been used in tens of thousands of procedures across more than 30 countries on five continents. The company intends to seek further regulatory clearances so that indications may be expanded to other types of surgeries such as general or gynecologic procedures within the U.S.
For more details about this announcement or information about Medtronic’s broader offerings including its Touch Surgery ecosystem, visit www.Medtronic.com/hugoishere.
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