Medtronic submits 510(k) filings to expand Hugo™ robotic-assisted surgery system into general and gynecologic specialties in the United States

Medtronic (NYSE: MDT) announced multiple U.S. milestones for its Hugo™ robotic-assisted surgery (RAS) system, aimed at expanding into general and gynecologic surgery.

Rhea-AI Summary

Medtronic (NYSE: MDT) announced multiple U.S. milestones for its Hugo™ robotic-assisted surgery (RAS) system, aimed at expanding into general and gynecologic surgery.

The company submitted 510(k)s for general and gynecologic indications and the LigaSure™ RAS Maryland instrument, received 510(k) clearance for ProGrip™ Advanced mesh for robotic ventral hernia repair, and completed enrollment in the Embrace Gynecology IDE study.

Positive

• Multiple 510(k) submissions to expand Hugo™ RAS into general and gynecologic surgery
• 510(k) clearance received for ProGrip™ Advanced mesh in robotic ventral hernia repair
• 510(k) submitted for LigaSure™ RAS Maryland instrument on Hugo™ RAS system
• Embrace Gynecology IDE study enrollment completed with 70 patients at 5 U.S. hospitals
• Hugo™ RAS already FDA-cleared for urologic procedures and in use at U.S. centers

Negative

• General and gynecologic Hugo™ RAS indications remain pending FDA 510(k) clearance
• LigaSure™ RAS Maryland instrument U.S. use dependent on future 510(k) decision
• Embrace Gynecology IDE study has enrollment complete but no clinical outcomes reported

Argus Jun 3 session

+5.69% close to close Open Argus

Details

News Market Reaction – MDT

On Jun 3, the day this news came out, MDT closed 5.69% above the previous close.

Data tracked by StockTitan Argus for the Jun 3 session.

Key Figures

Hugo RAS experience: nearly five years Hugo RAS geographies: more than 35 countries LigaSure usage: more than 35 million procedures +5 more

Hugo RAS experience

nearly five years

Commercial use across more than 35 countries

Hugo RAS geographies

more than 35 countries

Commercial use for robotic-assisted surgery

LigaSure usage

more than 35 million procedures

Vessel-sealing technology across 65+ countries

LigaSure countries

65+ countries

Global reach of LigaSure vessel-sealing technology

ProGrip mesh usage

more than 6 million procedures

Use of ProGrip meshes historically

Ventral hernia repairs

nearly 470,000 procedures per year

Annual U.S. ventral hernia repair volume

Embrace Gynecology enrollment

70 patients

IDE study of Hugo RAS in gynecologic surgery

Embrace study sites

5 U.S. hospitals

Centers participating in Embrace Gynecology IDE study

Historical Context

5 past events · Latest: May 20

5 events

1. May 20

   Chronic pain acquisition

   24h Move

   -1.3%

   Plan to acquire SPR Therapeutics to expand chronic pain PNS offerings.

2. Apr 28

   CE Mark clearance

   24h Move

   -1.2%

   CE Mark for Stealth AXiS surgical system enabling spine and cranial use in Europe.

3. Apr 20

   CathWorks acquisition

   24h Move

   -1.4%

   Completion of CathWorks deal adding FFRangio AI-based coronary assessment system.

4. Apr 13

   Earnings date notice

   24h Move

   +0.9%

   Announcement of date and timing for Q4 and FY26 financial results release.

5. Mar 27

   FDA system clearance

   24h Move

   -0.6%

   FDA clearance for Stealth AXiS system for cranial and ENT procedures in U.S.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

510(k), ide, investigational device exemption, robotic-assisted surgery, +3 more

7 terms

510(k) regulatory

"Medtronic submits 510(k) filings to expand Hugo™ robotic-assisted surgery system"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

ide regulatory

"Embrace Gynecology Investigational Device Exemption (IDE) clinical study — completed enrollment"

An IDE (Investigational Device Exemption) is a regulatory permission that allows a company to test an unapproved medical device in human clinical trials to gather safety and effectiveness data. Think of it as a temporary road permit for a new product: getting the IDE moves a technology from concept toward approval and market access, which can reduce uncertainty and increase value for investors, while delays or denials raise development risk and potential costs.

investigational device exemption regulatory

"Embrace Gynecology Investigational Device Exemption (IDE) clinical study — completed enrollment"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device maker to test an unapproved device in people so the device’s safety and effectiveness can be studied. For investors, an IDE matters because it marks a formal step toward regulatory approval—like getting a temporary test-drive permit—and influences clinical cost, timelines, and the likelihood a device will reach the market and generate revenue.

robotic-assisted surgery medical

"Hugo™ robotic-assisted surgery (RAS) system in the United States"

Robotic-assisted surgery uses a surgeon-controlled robotic system to perform or assist with operations, where the doctor operates instruments through small incisions while a machine translates their movements into precise actions. For investors, it matters because these systems change procedure costs, hospital purchasing and training needs, and recurring revenue from instruments and service contracts—similar to how a new industrial robot can reshape manufacturing costs and output.

vessel-sealing technology medical

"LigaSure RAS incorporates vessel-sealing technology that has been used in more than 35 million"

A medical-device method that closes and seals blood vessels and tissue during surgery using controlled energy or pressure, allowing surgeons to stop bleeding quickly without stitches. Investors care because devices that make operations faster, safer, and less costly tend to be adopted by hospitals and surgeons, which can drive sales, recurring consumable revenue, and favorable reimbursement or regulatory outcomes—similar to how a faster, more reliable tool can boost productivity in any industry.

ventral hernia medical

"self-gripping polypropylene mesh for use in robotic-assisted ventral hernia repair surgeries"

A ventral hernia is a weakness or gap in the abdominal wall that lets internal tissue or organs push outward, often appearing as a bulge in the belly; it can arise after surgery or from pressure on the abdomen. Investors care because incidence and treatment of ventral hernias affect demand for surgical services, medical devices, hospital resources and insurance costs, and can influence sales, clinical results and reimbursement for healthcare companies.

trocar medical

"by making it easier to introduce through trocars, handle, deploy, and unfold"

A trocar is a pointed surgical tool used to create a small, controlled opening through the skin and tissue to provide a sealed doorway for other instruments or cameras during minimally invasive procedures. For investors, trocars matter because their demand and design (reusable vs. single-use, safety features, regulatory approval) influence sales, pricing, and hospital purchasing decisions in the surgical devices market—similar to how the quality of a key and lock affects access and security in a building.

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Company also announces 510(k) pending for LigaSure™ RAS Maryland instrument on the Hugo RAS system, and 510(k) clearance for ProGrip™ Advanced self-gripping polypropylene mesh for use in robotic-assisted ventral hernia repair surgeries

GALWAY, Ireland, June 3, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced significant milestones to unlock expanded indications for the Hugo™ robotic-assisted surgery (RAS) system in the United States and to shape the future of surgery.

• General surgery indication including hernia repair — 510(k) clearance submitted
• Embrace Gynecology Investigational Device Exemption (IDE) clinical study — completed enrollment
• Gynecologic surgery indication — 510(k) clearance submitted
• LigaSure™ RAS Maryland instrument — 510(k) clearance submitted
• ProGrip™ Advanced mesh for use in robotic-assisted ventral hernia repair — 510(k) clearance received

These milestones build momentum for Medtronic's Surgical business and its purposeful launch of the Hugo RAS system, which received FDA clearance for urologic surgical procedures in December 2025 and is in commercial use at leading U.S. medical centers. With nearly five years of commercial experience across more than 35 countries in five continents, the Hugo RAS system has been used in tens of thousands of procedures and its safety and effectiveness is supported by hundreds of independently published scientific papers.

Medtronic is the first and only company that can meet surgeons' needs across all surgical modalities — open, laparoscopic, and robotic-assisted — giving surgeons and health systems the choice and partnership required to build and grow successful surgery programs across care settings.

"These milestones and innovative technologies will unlock our ability to enhance the value of our partnership in general and gynecologic surgical procedures," said Matt Anderson, senior vice president and president of the Surgical business at Medtronic. "This isn't just a portfolio expansion, it's part of our ongoing commitment to unite instruments, intelligence, and human hands into one unique surgical ecosystem. One that enables every patient, everywhere, access to the best possible surgery."

Expanding Hugo™ RAS indications and capabilities
The 510(k) filings for Hugo RAS system use in general surgery and gynecological procedures would significantly broaden the platform's clinical applicability in the U.S. and address growing demand for robotic-assisted minimally invasive options in these high-volume specialties. Medtronic has decades of experience collaborating with surgical teams in general surgery and gynecologic surgery to advance patient care globally; they are also indications where the Hugo RAS system is in clinical use in major markets outside the U.S. 

Bringing together technology surgeons trust and furthering its commitment to continually enhancing Hugo™ RAS system capabilities, today Medtronic announced it has submitted a 510(k) filing to the FDA for the LigaSure RAS Maryland instrument.

Designed exclusively for use with the Valleylab™ FT10 energy platform on the Hugo™ RAS system, LigaSure RAS incorporates vessel-sealing technology that has been used in more than 35 million procedures across 65+ countries. LigaSure RAS was introduced on the Hugo RAS system in Europe in 2025.

"LigaSure technology has been transformative for surgery and integrating it onto the Hugo RAS system gives surgeons greater confidence and control during critical moments in complex procedures," said Dr. Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing general surgeon. "As more and more surgeons and patients demand robotic-assisted surgery, we need more access to technology and training, and Medtronic brings that choice in a very powerful way."

Our most advanced robotic mesh^1-3,†
Today Medtronic also announced it received FDA clearance for ProGrip™ Advanced, an evolution of existing mesh technologies to better align with the specific demands of robotic-assisted ventral hernia repair.

ProGrip meshes have been used in more than 6 million procedures. ProGrip Advanced supports surgical efficiency in robotic procedures by making it easier to introduce through trocars, handle, deploy, and unfold compared to previously available products and comes in a variety of sizes to meet each patient's needs.^2-3,‡

Every year, nearly 470,000 ventral hernia repair procedures are performed in the U.S. — more and more are being done with the assistance of a robot, and an increasing number are performed at alternative sites of care as hospitals shift lower acuity procedures to ambulatory centers to support a patient-centered approach to care while managing cost pressures and capacity challenges. The Medtronic surgical ecosystem across open, laparoscopic, and robotic-assisted surgery is uniquely positioned to help solve these problems.

Enrollment complete in Embrace Gynecology IDE study for the Hugo™ RAS system
Medtronic also announced today that the company has completed enrollment in the Embrace Gynecology Investigational Device Exemption (IDE) clinical study for the Hugo™ RAS system in the U.S. Embrace Gynecology is a prospective multicenter study to evaluate the safety and effectiveness of the Hugo™ RAS system when used in robotic-assisted gynecologic procedures. The study enrolled 70 patients across 5 U.S. hospitals.

For more information, visit medtronic.com/hugoishere.

†Compared to all Medtronic meshes indicated for robotic ventral hernia repair.

‡Bench testing may not be indicative of clinical performance.

1. Based on internal report 43463CR757, Memorandum — ProGrip™ advanced self-gripping polypropylene mesh — advanced robotic mesh.
2. Based on internal report 43463CR506, Design verification report. 
3. Based on internal report 43463CR740, Design validation lab of ProGrip™ advanced self-gripping polypropylene mesh by MIS and open surgical approach.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow on LinkedIn.

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.

Contacts:
Gary Jeanfaivre
Public Relations
+1-203-556-0777

Ingrid Goldberg
Investor Relations
+1-763-505-2696

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SOURCE Medtronic plc

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What 510(k) submissions did Medtronic file for the Hugo™ RAS system in June 2026 (MDT)?

Medtronic submitted 510(k) filings to expand Hugo™ RAS use to general and gynecologic surgery and for the LigaSure™ RAS Maryland instrument. According to Medtronic, these submissions aim to broaden U.S. access to robotic-assisted minimally invasive procedures in high-volume specialties.

What FDA clearance did Medtronic receive for ProGrip™ Advanced mesh related to Hugo™ robotic surgery (MDT)?

Medtronic received 510(k) clearance for ProGrip™ Advanced self-gripping polypropylene mesh for robotic-assisted ventral hernia repair. According to Medtronic, the mesh is designed to ease trocar introduction, handling, deployment, and unfolding in robotic procedures and is offered in multiple sizes.

How does the Embrace Gynecology IDE study support Hugo™ RAS expansion for Medtronic (MDT)?

The Embrace Gynecology IDE study evaluates safety and effectiveness of the Hugo™ RAS system in gynecologic procedures. According to Medtronic, enrollment is complete with 70 patients across five U.S. hospitals, providing U.S. clinical experience to support potential gynecologic indications.

What existing FDA indication does the Hugo™ robotic-assisted surgery system already have in the U.S. (MDT)?

Hugo™ RAS already holds FDA clearance for urologic surgical procedures in the United States. According to Medtronic, the system is in commercial use at leading U.S. medical centers and has nearly five years of global experience across more than 35 countries.

How widely used is Medtronic’s Hugo™ RAS system and LigaSure™ technology globally (MDT)?

The Hugo™ RAS system has been used in tens of thousands of procedures across more than 35 countries. According to Medtronic, LigaSure™ vessel-sealing technology has been employed in over 35 million procedures in 65+ countries, now being integrated onto Hugo™ RAS.

What clinical need does Medtronic target with ProGrip™ Advanced mesh in ventral hernia repair (MDT)?

ProGrip™ Advanced targets robotic-assisted ventral hernia repairs, of which nearly 470,000 are performed annually in the U.S. According to Medtronic, the mesh aims to support surgical efficiency as more hernia procedures move to robotic platforms and alternative sites of care.