Medtronic gets FDA nod for Hugo surgical robot for urology

Medtronic

(NYSE: MDT)
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announced today that the FDA cleared its Hugo robotic-assisted surgery system for use in urologic surgical procedures.

The landmark regulatory milestone for the medtech giant is the first in the U.S. for its soft-tissue surgical robot. Medtronic unveiled Hugo in September 2019 as a potential competitor to long-time industry leader Intuitive Surgical. The company submitted the platform to the FDA for the urology indication in April. It has since met its endpoints in a hernia repair study and been put under evaluation in a study for gynecological procedures as well.

Outside the U.S., Hugo has been used in tens of thousands of urologic, gynecologic, and general surgery procedures in more than 30 countries across 5 continents. Now, Hugo’s clearance brings a versatile robotic-assisted platform to U.S. surgeons and health systems seeking to expand soft-tissue robotic surgery programs and access to minimally invasive care, the company said in a news release.

Medtronic’s surgical robot is a modular, multi-quadrant platform designed for various surgical procedures. It features wristed instruments, 3D visualization and surgical video capture options in the Touch Surgery ecosystem.

“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 Robotic Surgical Technologies at Medtronic. “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.”

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More about the differentiators for the Medtronic Hugo platform

Medtronic says Hugo’s modular design means the robotic arms can be easily moved, shared, and deployed across any care setting. This helps to maximize utilization and provide surgeons with the flexibility to customize their approaches to each patient’s unique needs.

Hugo also has an open design for its surgeon console, providing greater situational awareness and visualization. Medtronic said it reduces physical strain and creates enhanced training opportunities for surgical teams.

Touch Surgery, meanwhile, provides pre-operative training tools, remote tele-proctoring capabilities and AI-powered post-operative insights. Surgeons can access case videos minutes after completing a procedure. This supports continuous improvement and collaboration among hospital teams and with peers in the surgical community.

Medtronic said Hugo makes it the first and only company capable of meeting surgeons’ needs across all surgical modalities. That extends to open laparoscopic and robotic-assisted surgeries. With the clearance, Hugo can assist in minimally invasive urologic surgical procedures such as prostatectomy, nephrectomy, and cystectomy. The company says these common procedures account for about 230,000 surgeries per year in the U.S.

Beyond urology, the company intends to pursue indications for general and gynecologic surgical procedures, too.

“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 Robotic Surgical Technologies and Digital Technologies within the Surgical business 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.”

The analysts’ take on the Hugo news

BTIG analysts Ryan Zimmerman and Iseult McMahon maintain a “Neutral” rating for Medtronic on the back of the news. They note that clearance comes at the front end of the company’s targeted timeframe for the regulatory green light.

The analysts say that while Hugo had availability outside the U.S. for more than four years, bringing the robot to the U.S. — the world’s largest robotics market — “is seminal to” the company’s long-term growth.

“In terms of expectations, we think investors assumed clearance would come but are not building in rapid uptake in the U.S. as unit placements are likely to grow at a more measured pace,” the analysts said. “Intuitive Surgical’s [da Vinci 5] remains in a strong position having seen growing adoption and rapid uptake above and beyond prior [da Vinci] systems.”

The analysts think the growing demand for leasing arrangements may suit Medtronic well. They expect Intuitive to perform around 190,000 urologic procedures in 2025, suggesting market domination at 83% penetration, given Medtronic’s estimates for approximately 230,000 surgeries in the urology space per year in the U.S. The analysts also note that an advantage of Hugo compared to da Vinci is the open console, citing a doctor who performed the first procedure with Hugo in 2022.

“As [Medtronic] picks up additional clearances, we think momentum can begin to build,” the analysts said. “We also would note that given [Medtronic’s] size and scale, we would not be surprised to see [Medtronic] bundle Hugo with other products to health systems in order to place more systems and drive utilization of instrumentation.”

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