Medtronic Hugo Robotic-Assisted Surgery System Receives European CE Mark Approval

Multiple Hospitals Across Europe Set to be the First to Install Hugo™ RAS System and Expand the Benefits of Robotic-Assisted Surgery to Their Patients

- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it has received CE (Conformité Européenne) Mark for the Hugo™ robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe . CE Mark approval is for urologic and gynecologic procedures, which make up about half of all robotic procedures performed today.

"This day has been a long time coming, not just for Medtronic, but for the surgeons and hospital leaders who have partnered with us on this journey to bring the benefits of robotic-assisted surgery to more patients around the world. We know our solution is more meaningful because of their insights," said Megan Rosengarten , president of the Surgical Robotics business, which is part of the Medical Surgical Portfolio at Medtronic. "With the Hugo RAS system in our European customers' hands and our dedicated team by their side, together we will redefine what is possible in robotic-assisted surgery."

The Hugo RAS system was designed to address the historic cost and utilization barriers that have stifled robotic surgery adoption for two decades. Globally, about 3% of surgeries are performed robotically, 1 despite offering patients the benefits of minimally invasive surgery — fewer complications, shorter hospital stays, and faster return to normal activities. 2–4,† In Western Europe , about 2% of procedures are done robotically while the majority, approximately 65%, are open surgery. 1 The remainder are traditional minimally invasive surgery. 1

"Robotics and artificial intelligence are the undeniable future of healthcare, with incredible potential to not only advance patient care, but increase access to these benefits," said Rob ten Hoedt, executive vice president and president of the Europe , Middle East , and Africa (EMEA) region at Medtronic. "The Hugo RAS system builds on our leadership in minimally invasive surgery, and we're thrilled to provide hospitals across Europe a robotic-assisted surgery system that is thoughtfully designed to meet their needs today and tomorrow. We've had strong interest from leading surgical centers across Europe and expect to move quickly with multiple installations in several countries."

These hospitals will be the first in Europe to join Medtronic's Partners in Possibility Program, a group of pioneering institutions that will be among the first in the world to use the Hugo RAS system and participate in the global patient registry. Clinicians from these hospitals will participate in hands-on training at Medtronic Surgical Robotics Experience Centers, including two flagship sites operated in partnership with the ORSI Academy in Ghent, Belgium , and IRCAD in Strasbourg, France .

CE Mark approval comes on the heels of major milestones in the Hugo RAS system global launch, including the first urological and gynecological procedures, which took place in Latin America and India and marked the start of the Hugo RAS system global patient registry. A modular, multi-quadrant platform designed for a broad range of surgical procedures, the Hugo RAS system combines wristed instruments, 3D visualization, and a cloud-based surgical video capture option in Touch Surgery™ Enterprise with dedicated support teams specializing in robotics program optimization, service, and training.

The Hugo RAS system is commercially available in certain geographies. Regulatory requirements of individual countries and regions will determine approval, clearance, or market availability. In the EU, the Hugo RAS system is CE marked. In the U.S., the Hugo RAS system is an investigational device not for sale. Touch Surgery Enterprise is not intended to direct surgery, or aid in diagnosis or treatment of a disease or condition.

For more information, visit medtronic.com/hugo .

About Medtronic
Medtronic plc ( www.medtronic.com ), headquartered in Dublin, Ireland , is among the world's largest medical technology, services and solutions companies — alleviating pain, restoring health, and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

†Compared to open surgery.

1.

Based on internal estimates and Medtronic report, FY20 market model: procedural volume data.

2.

Fitch K, Engel T, Bochner A. Cost differences between open and minimally invasive surgery. Managed Care. 2015 Sep;24(9):40–48.

3.

Tiwari MM, Reynoso JF, High R, Tsang AW, Oleynikov D. Safety, efficacy, and cost effectiveness of common laparoscopic procedures. Surg Endosc. 2011;25(4):1127-1135.

4.

Roumm AR, Pizzi L, Goldfarb NI, Cohn H. Minimally invasive: minimally reimbursed? An examination of six laparoscopic surgical procedures. Surg Innov. 2005;12(3):261–287.

Contacts:




Gary Jeanfaivre

Ryan Weispfenning

Public Relations

Investor Relations

+1-203-833-2104

+1-763-505-4626

Medtronic plc (PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-hugo-robotic-assisted-surgery-system-receives-european-ce-mark-approval-301396644.html

SOURCE Medtronic plc

News Provided by Canada Newswire via QuoteMedia

The Conversation (0)
Medtronic chairman and CEO Geoff Martha to speak at Bernstein's Strategic Decisions Conference

Medtronic chairman and CEO Geoff Martha to speak at Bernstein's Strategic Decisions Conference

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced it will participate in Bernstein's 41st Strategic Decisions Conference on Thursday, May 29, 2025 .

Geoff Martha , Medtronic chairman and chief executive officer, will make a formal presentation beginning at 11:00 a.m. EDT ( 10:00 a.m. CDT ). Immediately following the presentation, Martha will be joined by Thierry Piéton, Medtronic executive vice president and chief financial officer, to answer questions about the company.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Medtronic reports strong finish to its fiscal year with its fourth quarter financial results; announces dividend increase

Medtronic reports strong finish to its fiscal year with its fourth quarter financial results; announces dividend increase

Building momentum in key franchises including Pulsed Field Ablation, TAVR, Cardiac Rhythm Management, Diabetes, Spine, and Neuromodulation

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced financial results for its fourth quarter (Q4) and fiscal year 2025 (FY25), which ended April 25, 2025 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic announces intent to separate Diabetes business

Medtronic announces intent to separate Diabetes business

Enables intense focus on highest margin growth drivers where Medtronic has leading core competencies

Leading, scaled, direct-to-consumer Diabetes business poised to become standalone company; only company with a complete ecosystem to address intensive insulin management

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

  • FDA Breakthrough Device Designation Awarded to AVIM Therapy
  • FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

Q1 2025 Highlights:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

Star Jones , award winning television personality & women's heart health advocate,   helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×