Medtronic announces FDA clearance for LigaSure™ RAS Maryland instrument on the Hugo™ RAS system

FDA clearance adds Medtronic’s established LigaSure vessel-sealing technology to the Hugo robotic-assisted surgery system for U.S. surgeons.

Rhea-AI Summary

Medtronic (MDT) received FDA clearance for the LigaSure™ RAS Maryland jaw instrument on its Hugo™ robotic-assisted surgery (RAS) system.

The decision adds Medtronic’s LigaSure vessel-sealing technology to the Hugo RAS instrument portfolio for U.S. robotic-assisted procedures. The LigaSure RAS Maryland device, used with the Valleylab™ FT10 energy platform, seals and cuts vessels, thick tissue, and lymphatics up to 7 mm in diameter in approximately 2 seconds while aiming to minimize thermal spread. It is the first robotic-driven LigaSure instrument and is based on technology used in more than 45 million procedures across over 65 countries. The device was previously introduced on the Hugo RAS system in Europe in 2025 following CE Mark.

Positive

• FDA clearance for LigaSure™ RAS Maryland jaw instrument on Hugo™ RAS system in the U.S.
• First robotic-driven LigaSure leverages technology used in more than 45 million procedures across 65+ countries.
• Technical capability: seals and cuts vessels and tissue up to 7 mm in about 2 seconds.

Negative

• None.

Key Figures

Vessel diameter capacity: up to and including 7 mm Sealing time: approximately 2 seconds Prior procedure usage: more than 45 million procedures +4 more

Vessel diameter capacity

up to and including 7 mm

LigaSure RAS Maryland instrument

Sealing time

approximately 2 seconds

LigaSure RAS Maryland instrument

Prior procedure usage

more than 45 million procedures

LigaSure vessel-sealing technology

Technology geographic reach

65+ countries

LigaSure technology over the last two decades

European introduction

2025

LigaSure RAS Maryland instrument introduced following CE Mark

Hugo system geographic reach

more than 35 countries

Outside the U.S.

Surgical procedures covered

more than 50

Hugo RAS system outside the U.S.

Key Terms

fda, ce mark, thermal spread, lymphatics

4 terms

fda regulatory

"The U.S. Food and Drug Administration (FDA) has cleared"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

ce mark regulatory

"introduced on the Hugo™ RAS system in Europe in 2025 following CE Mark"

A CE mark is a regulatory stamp placed on products to show they meet the European Union’s basic safety, health and environmental rules and can be sold in the European Economic Area. For investors it matters because the mark unlocks market access, affects how quickly a product can generate revenue, and signals regulatory risk and potential compliance costs—think of it as a passport that lets a product enter a large market.

thermal spread medical

"while minimizing thermal spread to surrounding tissue"

Thermal spread is the unintended heating of tissue that extends outward from the point where an energy-based surgical device (like a cautery, laser, or ultrasonic tool) is applied. It describes how far and how much surrounding tissue is affected by heat beyond the target area; imagine heat from a hot pan warming nearby surfaces. For investors, thermal spread is a key safety and performance measure because it affects device claims, regulatory approval, liability risk, and clinical adoption.

lymphatics medical

"seals and cuts vessels, thick tissue, and lymphatics"

The lymphatics are the network of vessels, nodes and tissues that carry lymph — a fluid containing immune cells and waste — throughout the body, helping remove excess fluid and fight infections. For investors, the lymphatic system matters because many drugs, medical devices and diagnostics target its vessels or nodes to treat cancer, autoimmune disease, lymphedema and inflammatory conditions; understanding whether a therapy reaches or affects the lymphatics helps assess its potential clinical use and market relevance.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Trusted vessel-sealing technology used in more than 45 million procedures worldwide is now cleared for robotic-assisted surgery in the U.S.

GALWAY, Ireland, Sept. 16, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) has cleared the LigaSure™ RAS Maryland jaw device for use with the Hugo™ robotic-assisted surgery (RAS) system. The clearance expands the instruments available on the Hugo RAS system and brings Medtronic's trusted vessel-sealing technology to U.S. surgeons performing robotic-assisted procedures.

As robotic-assisted surgery adoption grows in the U.S., surgeons increasingly expect the same trusted energy instruments in a robotic workflow that they rely on in open and laparoscopic settings. The LigaSure RAS Maryland instrument meets that expectation, pairing a versatile robotic platform with vessel-sealing technology surgeons already know.

"Vessel sealing sits at the center of how surgeons work through the most demanding moments of a procedure, and surgeons have trusted LigaSure to do it across open and laparoscopic surgery for decades," said Dr. Matthew Kroh, chief medical officer within the Surgical business at Medtronic and a practicing surgeon. "Bringing that same performance to the Hugo RAS system in the U.S. means surgeons carry the confidence and control they already rely on into their robotic-assisted cases."

The Hugo RAS system is cleared for use in urologic surgical procedures in the U.S. and is in commercial use at a growing number of leading health systems and hospitals across the country. The company is continuing to progress its plans to expand Hugo indications to a broad range of soft-tissue surgical procedures in the U.S., including general and gynecologic surgical procedures. Outside the U.S., the Hugo RAS system has positively impacted the lives of tens of thousands of patients across more than 35 countries, spanning more than 50 different surgical procedures within urology, general, and gynecology indications.

Designed exclusively for use with the Valleylab™ FT10 energy platform on the Hugo™ RAS system, the LigaSure™ RAS Maryland instrument seals and cuts vessels, thick tissue, and lymphatics up to and including 7 mm in diameter, sealing vessels in approximately 2 seconds while minimizing thermal spread to surrounding tissue. As the first-ever robotic-driven LigaSure™ instrument, it incorporates vessel-sealing technology used in more than 45 million procedures across 65+ countries over the last two decades. The LigaSure RAS Maryland instrument was introduced on the Hugo™ RAS system in Europe in 2025 following CE Mark.

The addition of the LigaSure™ RAS Maryland instrument reflects Medtronic's commitment to meeting surgeons' needs across open, laparoscopic, and robotic-assisted surgical modalities, giving surgeons and health systems the choice and partnership to meet each patient's unique needs and build successful surgery programs.

Learn more at medtronic.com/LigaSureOnHugo.

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 types of procedures is the Hugo™ RAS system currently cleared for in the U.S.?

The Hugo™ RAS system is cleared for use in urologic surgical procedures in the U.S. and is in commercial use at a growing number of health systems and hospitals.

Where is the Hugo™ RAS system and LigaSure™ RAS Maryland instrument already in use outside the U.S.?

Outside the U.S., the Hugo™ RAS system has treated tens of thousands of patients in more than 35 countries across over 50 procedures in urology, general surgery, and gynecology. The LigaSure™ RAS Maryland instrument was introduced on the Hugo RAS system in Europe in 2025 after receiving CE Mark.

With which energy platform is the LigaSure™ RAS Maryland instrument designed to be used?

The LigaSure™ RAS Maryland instrument is designed exclusively for use with the Valleylab™ FT10 energy platform on the Hugo™ RAS system.