Medtronic Submits Hugo Robot for US FDA Approval

Medtronic Submits Hugo Robot for US FDA approval, marking a significant step towards challenging Intuitive Surgical’s long-standing dominance in the U.S. surgical robotics market.

Learn more about what this means for the surgical robotics market of the U.S., how this drives growth in the surgical business, how it provides surgeons and hospitals with a competitive alternative, and more.

 

 

Table of Contents:

➜ What is Medtronic Hugo?

➜ Is Medtronic Hugo FDA approved?

⤷ What was Medtronic Hugo submitted to the FDA for?

➜ Expanding Hugo’s Reach: Trials Underway for Hernia, Benign, and Oncologic Gynecology

➜ Medtronic Hugo’s Market Impact

➜ Medtronic’s Hugo vs Intuitive’s Da Vinci

⤷ Hugo vs Da Vinci

➜ Who Competes with Medtronic in the U.S. Surgical Robotics Market?

➜ Medtronic Hugo FDA Summary

➜ Explore Comprehensive U.S. Surgical Robotics and Navigation Market Report Today

 

Key Takeaways

• Medtronic submitted its Hugo™ robotic-assisted surgery system to the FDA in Q1 2025, with an initial focus on urologic procedures like prostatectomies and nephrectomies.
• The submission is supported by clinical trial success, with Hugo demonstrating a 98.5% surgical success rate and favorable complication data in the Expand URO study.
• Additional trials are underway for hernia, benign gynecology, and oncologic gynecology, signaling Medtronic’s strategy to expand Hugo’s surgical indications.
• Hugo is positioned as a modular, cost-effective alternative to Intuitive Surgical’s da Vinci®, offering AI-powered analytics, flexible system setup, and an open console for greater surgeon communication.
• Despite being newer, Hugo is already approved in 25+ countries, and U.S. FDA approval would mark a major shift in competitive dynamics within the world’s largest surgical robotics market.
• Intuitive Surgical remains the dominant market leader, especially in minimally invasive surgery (MIS), driven by its established da Vinci platform, broad instrument portfolio, and FDA-cleared da Vinci 5 system.
• Stryker and Smith & Nephew lead in orthopedic robotics, while Medtronic has also expanded into spinal robotics with the StealthStation™ platform and Mazor-acquired technologies.
• The entry of Medtronic’s Hugo in the U.S. market introduces greater competition, potentially reshaping purchasing behavior among hospitals and expanding robotic surgery access.

 

What is Medtronic Hugo?

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The Hugo Soft Tissue Robot, officially known as the Hugo™ RAS (Robotic-Assisted Surgery) system, is Medtronic’s entry into the surgical robotics market. It’s designed to assist surgeons in performing a wide range of minimally invasive soft tissue surgeries.

The Hugo system, with its modular design and focus on accessibility, aims to provide a competitive alternative, potentially driving innovation and expanding the adoption of robotic surgery while offering surgeons more choice. Positive clinical trial results support this submission, and further approvals for other surgical specialties are anticipated.

 

Is Medtronic Hugo FDA approved?

Medtronic submitted its Hugo robotic-assisted surgery system for FDA approval in the first quarter of 2025. This is a crucial step for Medtronic to enter the U.S., the world’s largest robotic surgery market, where Intuitive Surgical has been the dominant player for over two decades.

What was Medtronic Hugo submitted to the FDA for?

Medtronic submitted the Hugo robotic-assisted surgery system to the FDA for approval in urologic procedures. 

This includes surgeries like: 

• prostatectomies
• nephrectomies
• cystectomies

 

The submission is based on data from their Expand URO clinical study, which demonstrated the system’s safety and effectiveness, with a high surgical success rate of 98.5% and favorable complication rates.

 

Expanding Hugo’s Reach: Trials Underway for Hernia, Benign, and Oncologic Gynecology

Medtronic has also completed enrollment in studies for hernia and benign gynecology and has received approval to begin a trial for oncologic gynecology procedures. The data from these studies will support future submissions to the FDA for expanding the Hugo’s approved uses.

This will allow Medtronic to address a wider range of surgical needs and further compete with established players like Intuitive Surgical across multiple surgical specialties.

 

Medtronic Hugo’s Market Impact

Intuitive Surgical currently holds a significant technological edge. This advantage stems from the widespread adoption of their da Vinci system, coupled with its extensive range of instruments and accessories. 

Despite Intuitive’s lead, the arrival of Medtronic’s Hugo, along with other companies that may be developing or introducing robotic surgery systems, is expected to inject significant competition into the U.S. market.

This increased competition might lead to longer selling cycles for all players as physicians prefer to have options.

 

Medtronic’s Hugo vs Intuitive’s Da Vinci

The Medtronic Hugo™ RAS (Robotic-Assisted Surgery) system and the Intuitive Surgical da Vinci Surgical System are both advanced robotic platforms designed to assist surgeons in performing minimally invasive surgeries.

Hugo vs Da Vinci:

1. System Design

• Hugo™: Modular setup with individual arm carts and an open console for better OR flexibility and communication.
• da Vinci®: Integrated design with an enclosed console and unified patient cart.
  

 

2. Surgeon Console & Ergonomics

• Hugo™: Open console allows natural posture and team interaction; uses passive 3D with glasses.
• da Vinci®: Enclosed console offers immersive 3D vision but isolates the surgeon; optimized for ergonomic comfort during long procedures.

 

3. Visualization & Endoscopes

• Hugo™: Uses Karl Storz 3D HD endoscope, mountable on any arm.
• da Vinci®: Proprietary stereoscopic endoscope with high-definition 3D view.

 

4. Instrument Control

• Hugo™: Pistol-grip controllers, longer rotation range (520°).
• da Vinci®: Streamlined instrument change and broader instrument variety.
• Both: 7 degrees of freedom and tremor filtration.

 

5. Instrument Portfolio

• Hugo™: Currently limited; relies on assistant for some tools.
• da Vinci®: Wide array of advanced robotic tools including staplers and sealers.

 

6. AI & Digital Integration

• Hugo™: Touch Surgery™ Enterprise offers AI-powered video segmentation and analytics.
• da Vinci®: MyIntuitive provides surgical data and performance insights.

 

7. Portability

• Hugo™: Modular, more portable and space-efficient.
• da Vinci®: Bulkier and less flexible for room-to-room movement.

 

8. Cost

• Hugo™: Positioned for affordability and broader access.
• da Vinci®: Higher upfront and recurring costs due to proprietary instruments.

 

9. Market Presence

• Hugo™: Newer; approved in 25+ countries and seeking U.S. FDA approval.
• da Vinci®: Over 20 years on the market with extensive global adoption and clinical validation.

 

Hugo™ targets cost-efficiency and flexibility with modular design and AI features, while da Vinci® leads in clinical experience, instrument range, and global presence. Hospitals will choose based on budget, specialty focus, and OR needs.

 

Who Competes with Medtronic in the U.S. Surgical Robotics Market?

Intuitive Surgical: Market Leader in MIS Robotics

• In 2023, minimally invasive surgery (MIS) robotic systems made up over 70% of the total surgical robotics market value. 
• Intuitive Surgical led this segment due to both strong capital equipment sales and a high volume of procedures, driving recurring demand for disposable instruments and accessories, which account for nearly 70% of the MIS market. 
• The company strengthened its position with the FDA clearance of the da Vinci 5 in March 2024, adding over 150 upgrades including 3D imaging, force feedback, and enhanced accuracy.

Stryker and Smith & Nephew: Leaders in Orthopedic Robotics

• The orthopedic robotic system market, which comprised over 10% of the overall surgical robotics market in 2023, was led by Stryker and Smith & Nephew.
• Stryker’s Mako™ system, used in hip and knee arthroplasty, surpassed 500,000 procedures by 2024, doubling its 2021 total.
• Smith & Nephew’s CORI™ system remains a major contender, offering a wider range of compatible implants than Mako™, appealing to hospitals seeking implant flexibility.

Medtronic: Expanding into MIS and Spinal Robotics

• Medtronic dominated the surgical navigation market in spine, ENT, and neurosurgery in 2023 with its StealthStation™ S8 and ENT systems.
• Following its acquisition of Mazor Robotics, Medtronic also became the top player in robotic-assisted spinal surgery. 
• The company further expanded into minimally invasive surgical robotics with its Hugo™ RAS platform, strengthening its footprint across multiple specialties.

 

Medtronic Hugo FDA Summary

• Medtronic’s FDA submission for the Hugo robot for urologic procedures marks a significant step towards its entry into the U.S. surgical robotics market. 
• Positive results from their clinical trials support this submission, and the company is also working on gaining approval for additional surgical indications. 
• This development is expected to introduce more competition in a market that has been largely dominated by Intuitive Surgical.

 

Explore Comprehensive U.S. Surgical Robotics and Navigation Market Report Today!

For an in-depth understanding of these trends, delve into our detailed 2024 – 2030 U.S. Surgical Robotics and Navigation Market Report.

This report offers a comprehensive analysis of the U.S. Surgical Robotics and Navigation Market, covering:

• Surgical Navigation: Orthopedic, Spine, Neurosurgery, ENT systems.
• Surgical Robotics: MIS, Orthopedic, Spinal, Neurosurgery, Radiosurgery, and Vascular Catheter systems.
• AR Technology: Augmented Reality-based navigation included in the appendix.

 

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