Medtronic has earned U.S. Food and Drug Administration (FDA) clearance for its Hugo robotic-assisted surgery (RAS) system for use in urologic surgical procedures.

Clearance for the Hugo RAS system brings a new, versatile robotic-assisted platform to U.S. surgeons and health systems looking to extend soft-tissue robotic surgery programs and access to minimally invasive care.

According to Medtronic, the U.S. leads the world in robotic surgery adoption, but hospitals are still facing challenges with capacity and access. The company said introducing the Hugo RAS system in the U.S. helps fill this gap with an innovative approach to robotic-assisted surgery.

“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, VP and GM of Medtronic’s Robotic Surgical Technologies 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.”

Hugo was cleared for use in minimally invasive urologic surgical procedures including prostatectomy, nephrectomy, and cystectomy—common procedures that account for about 230,000 surgeries per year in the U.S.

Hugo RAS system’s differentiators from other robotic systems

A modular design means Hugo’s robotic arms can be easily moved, shared, and deployed in various care settings. This means surgeons can be flexible to customize their approach to optimize anatomical access for each patient’s needs, Medtronic said. The surgeon console’s open design also offers more situational awareness and visualization, lowers physical strain, and creates more training opportunities.

Hugo connects with the Touch Surgery ecosystem, which offers pre-op training tools, remote tele-proctoring capabilities, and artificial intelligence (AI)-powered post-op case insights. Surgeons can securely access case videos seconds after a surgery is done to support continuous improvement and collaborations.

Medtronic said it’s the first and only company that can meet surgeon needs in open, laparoscopic, and robotic-assisted modalities. Adding Hugo offers access to robotic training, deep clinical and technical expertise, and choice to determine surgical approach for each patient’s needs.

“The Hugo RAS system represents a new and exciting approach to robotic-assisted surgery,” said Dr. James Porter, a urologic surgeon and chief medical officer for Medtronic’s Robotic Surgical Technologies and Digital Technologies businesses. “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.”

Outside the U.S., the Hugo RAS system has been used in tens of thousands of urologic, gynecologic, and general surgery procedures in more than 30 countries across five continents. It was first cleared in the EU for urologic and gynecologic procedures in October 2021, and received a Health Canada license for the same in December 2021.

Medtronic plans to expand the Hugo RAS system’s use in the U.S. to more surgical specialties over time, with indications for general and gynecologic surgical procedures expected to follow the initial urology clearance.