Hugo is heading to the U.S., with Medtronic finally securing a stateside clearance for its robotic surgery platform.
The FDA granted an initial green light to the soft-tissue system for urologic surgeries—though Medtronic has said it plans to soon expand the robot’s reach into high-volume hernia repairs and minimally invasive gynecology procedures, and, eventually, general surgery, following recent pivotal trials and its use in clinics overseas.
“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,” Rajit Kamal, vice president and general manager of Medtronic’s robotic surgical technologies segment, said in a statement.
“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,” Kamal added.
The FDA’s clearance includes minimally invasive, multiport procedures to remove parts or all of the prostate, kidneys and bladder, which the company said covers about 230,000 surgeries performed annually in the U.S.
Hugo features multiple robotic arms placed on individual wheeled carts, with the goal of making the device both portable and modular. Medtronic said it can be deployed across any healthcare setting.
The robot also taps into the medtech giant’s Touch Surgery digital platforms, encompassing artificial intelligence and video education programs for clinicians, as well as pre-op planning and live telesurgery connections.
Hugo has previously collected regulatory green lights in Europe, Canada, Japan and elsewhere, with the company saying it has logged tens of thousands of procedures in more than 30 countries and five continents since its 2021 debut in South America.
In September, Medtronic put forward clinical data from a successful trial in ventral and inguinal hernia repairs spanning 193 participants. Hugo was able to deliver zero mid-procedure conversions to traditional surgical methods or switches to another robotic platform while meeting its safety and effectiveness endpoints. The trial recorded average hospital stay times of about five to seven hours.
Medtronic’s cart-based approach will compete in hospitals and ambulatory surgical centers with systems from international players like CMR Surgical and Distalmotion, both of which secured FDA green lights in late 2024.
Distalmotion’s Dexter robot snagged a de novo clearance in outpatient inguinal hernia repairs, while CMR’s Versius clipped a de novo nod for gallbladder removals. Both companies have also posted nine-figure financing rounds this year as they look to expand in the U.S. market.
Meanwhile, Johnson & Johnson has been making strides with its Ottava platform, with robotic arms built into the operating table itself. Its first U.S. clinical cases included a gastric bypass procedure this past April, with an FDA submission slated for early next year.
Of course, they all aim to take a chunk out of the market share of the industry's leader, Intuitive, with its da Vinci 5 system going international this year.