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FDA clears the Medtronic Hugo™ robotic-assisted surgery system for urologic procedures.
NORTHAMPTON, MA / ACCESS Newswire / December 15, 2025 / James Choate-Deeds and his wife Caryn held hands and braced themselves for the test results.
"It's a gut-punch for sure to hear the words, ‘you have cancer†,'" he said. "Caryn gripped my hand tighter and we cried our eyes out. But then you get completely focused on what to do about it."
At 57, James was young to face prostate cancer (the average age of diagnosis is 66). He had always been active, athletic, and healthy, with no family history, so the news hit hard. But he soon realized he had a lot going for him.
"They found it early and it wasn't an aggressive form of the cancer," he said. "I had time to do my homework and make a decision on treatment. That's how I learned about Hugo."
Robotic-assisted surgery
Robotic-assisted surgery (RAS) is an advanced form of minimally invasive surgery. It's gained acceptance over the last two decades as a preferred method for prostate removal (prostatectomy), because of the benefits to patients and surgeons compared to traditional approaches.
The Hugo™ RAS system is the first soft-tissue robot from Medtronic and was recently cleared by the U.S. Food and Drug Administration (FDA) for urologic surgical procedures such as prostate removal. At the time of James' prostatectomy, the Hugo™ RAS system was still in clinical trials.
"I'm an architect and I know the benefits of working with cutting-edge technology," James said. "So when my surgeon told me Hugo represented the next generation of surgical technology and he considered it the best tool for the job, that's all I needed to hear."
How it works
The Hugo™ RAS system features four robotic arms that replicate the movements of human hands. Each arm can hold tiny instruments and a camera and be stationed anywhere around the operating table based on each patient's unique needs. The surgeon wears 3D glasses, sits at an open workstation with a 33-inch visual display, and performs surgery by precisely manipulating the robotic arms with controls at the workstation.
"It's definitely video-based, but it's not a video game," said Dr. James Porter, a urologic surgeon and Chief Medical Officer for Robotic Surgical Technologies and Digital Technologies within the Surgical business at Medtronic. "It's a coordinated effort between your hands, feet and eyes. The robotic arms have joints that help mimic human movements but are obviously much steadier. It allows us to be incredibly precise with suturing, among other things during surgery."
Dr. Porter performed James' surgery-one of nearly 6,000 robotic-assisted surgeries he has performed in his career to-date. Dr. Porter advised Medtronic scientists, engineers, and researchers for five years during the development of the Hugo™ RAS system and sees several important benefits with the new robotic system:
Better vision: 3D imaging improves the depth of vision during surgery.
Better access: Modular robotic arms can be positioned anywhere to give surgeons more flexibility to reach target anatomy and potentially enable robotic approaches for more patients.
Easier communication and better ergonomics: The surgeon operates Hugo™ RAS's robotic arms from a seated, open workstation that is comfortable for the doctor and allows for easier communication with the rest of the surgical team.
"All of these things are designed to enable surgeons to deliver the best possible care," said Dr. Porter. "Ultimately that's why we do what we do. To make life better for patients."
Future of Surgery
About 90% of the world's surgeries are still done without robotics, and 60% of them are open surgeries,1 meaning limited patient access to the benefits of minimally invasive surgery-fewer complications, shorter hospital stays and faster recovery.2,3,4
The Hugo™ RAS system is currently FDA-cleared for urologic surgical procedures. Medtronic is planning to pursue additional indications in the U.S., including general surgery and gynecologic indications-consistent with indications that the Hugo™ RAS system has in more than 30 countries around the world.
"The benefit to patients is enormous because robotic-assisted procedures are so precise," said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business at Medtronic. "Robotics and digital technologies are also shaping the future of surgery-a future where we believe surgery will be more precise, predictable and personalized."
Dr. Porter believes the next big evolution in surgery combines robotic hardware like the Hugo™ RAS system with software, including artificial intelligence.
"For example, someday I'll have real-time access during surgery to a 3D model of the organ I'm operating on," he said. "And see a digital analysis of the optimal angle to use an instrument. Imagine how important that information could be to a surgeon during surgery-and how it will further enable patient access. That's the kind of thing our digital team is working on."
Dr. Porter joined Medtronic in large part to contribute to that future. In the meantime, he still sees patients like James.
Two-and-a-half years later, James hikes, snow-skis, plays hockey, and travels extensively. All while maintaining his career in architecture.
"I don't sit down very often," he laughed. "Thanks to my great surgical team and Hugo, the procedure and recovery felt easy. Life is fabulous. I'm incredibly grateful for the technology that helped make that possible."
Learn more: How AI is changing the way your doctor performs surgery.
†The demonstration of safety and effectiveness for the urologic surgical procedures discussed in the labeling was based on evaluation of the device as a surgical tool that assists in the accurate control of robotically-controlled instruments to perform coordinated surgical tasks. The evaluation did not include assessment of outcomes related to the treatment of cancer (e.g., overall survival, disease-free survival, local recurrence) or any specific treatment of any underlying disease or condition.
Important Safety Information
The Medtronic Hugo™ RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, or market availability. Indications for use may vary.
Indications, Safety & Warnings
Indications for Use
The Hugo™ Robotic-Assisted Surgery (RAS) system is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive urologic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative surgical procedures set forth in the Hugo™ RAS System Indications Document.
Potential Adverse Events
The potential adverse events associated with the use of robotically assisted surgical devices include, but are not limited to: arrhythmia, bleeding, blunt trauma, bowel perforation, burns (varying degrees, bowel, thermal), crushing injury, delay of treatment (prolonged procedure), electric shock, foreign body in patient, infection, inflammation, tissue damage/trauma, vessel perforation.
Contraindications
There are no device specific contraindications for the Hugo™ RAS system.
The demonstration of safety and effectiveness for the urologic surgical procedures discussed in the labeling was based on evaluation of the device as a surgical tool that assists in the accurate control of robotically-controlled instruments to perform coordinated surgical tasks. The evaluation did not include assessment of outcomes related to the treatment of cancer (e.g., overall survival, disease-free survival, local recurrence) or any specific treatment of any underlying disease or condition.
Refer to Hugo™ RAS system user's guide, indications supplement and other supplemental labeling for detailed information regarding the procedures, indications, contraindications, warnings, precautions, and potential complications/adverse events. Contact Medtronic at rs.globalroboticsservicesupport@Medtronic.com to request the latest version or visit Medtronic.com/manuals
©2025 Medtronic. Medtronic, Medtronic logo and Engineering the Extraordinary are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 12/2025 WF 20445123 US-RP-2500171
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