Medtronic announces first surgery with Hugo™ robotic-assisted surgery system in the U.S. performed at Cleveland Clinic

Rhea-AI Summary

Medtronic (NYSE:MDT) announced that the first U.S. commercial surgical case using the FDA-cleared Hugo™ robotic-assisted surgery (RAS) system was performed at Cleveland Clinic on Feb. 17, 2026, where a robotic-assisted prostatectomy was completed and the patient discharged the next day.

The Hugo RAS system completed the Expand URO IDE study meeting primary safety and effectiveness endpoints and is available in more than 35 countries; Medtronic plans indication expansion into gynecologic and general surgery.

Positive

• First U.S. commercial Hugo RAS case completed at Cleveland Clinic on Feb. 17, 2026
• Patient discharged the day after the robotic-assisted prostatectomy
• Expand URO IDE study met primary safety and effectiveness endpoints
• Global availability: Hugo RAS system available in more than 35 countries

Negative

• U.S. indication limited to urology initially; gynecologic and general surgery indications pending
• No commercial revenue or guidance disclosed for Hugo RAS in the announcement

Key Figures

Robotic share of urologic abdominal surgeries: 80% Countries with Hugo RAS availability: more than 35 countries

2 metrics

Robotic share of urologic abdominal surgeries 80% Share of urologic abdominal surgeries in the U.S. using robotic systems

Countries with Hugo RAS availability more than 35 countries Global availability of the Hugo RAS system

Market Reality Check

Price: $99.49 Vol: Volume of 10,354,527 is s...

normal vol

$99.49 Last Close

Volume Volume of 10,354,527 is slightly above the 20-day average of 9,242,799. normal

Technical Trading above 200-day MA, with price at 99.49 versus MA(200) at 93.4, and about 6.43% below the 52-week high of 106.33.

Peers on Argus

MDT was down 1.38% while key medical device peers were mixed: SYK (-0.99%), BSX ...

MDT was down 1.38% while key medical device peers were mixed: SYK (-0.99%), BSX (-0.12%), EW (-0.98%), ZBH (+1.46%), and PHG (-0.03%). This points to largely stock-specific trading rather than a clear sector-wide move.

Historical Context

5 past events · Latest: Feb 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 13	Spine robotics clearance	Positive	-1.4%	FDA clearance for Stealth AXiS integrated spine surgery robotics platform.
Feb 11	Earnings date notice	Neutral	-0.3%	Announcement of Q3 FY26 earnings release and webcast schedule.
Feb 03	CathWorks acquisition	Positive	+0.5%	Intent to acquire CathWorks to expand interventional cardiology portfolio.
Feb 02	Diabetes FDA clearances	Positive	-0.2%	Medicare access and multiple FDA clearances for MiniMed 780G system.
Jan 23	Affera PFA milestones	Positive	-0.5%	CE Mark and first U.S. IDE cases for Sphere-360 PFA catheter.

Pattern Detected

Recent FDA clearances and technology launches have often coincided with flat-to-negative next-day moves, indicating a tendency for the stock to underreact or drift on positive product news.

Recent Company History

Over the past month, Medtronic has reported multiple innovation and regulatory milestones. On Jan 23, it highlighted CE Mark and first U.S. IDE cases for the Affera Sphere-360™ PFA catheter. Early February brought expanded Medicare access and FDA clearances for the MiniMed 780G system, followed on Feb 3 by the planned $585 million CathWorks acquisition. On Feb 13, the Stealth AXiS™ spine surgery platform received FDA clearance. Despite largely positive operational news, subsequent 24-hour price reactions were often modest or negative.

Market Pulse Summary

This announcement highlights Medtronic’s first U.S. commercial procedure with the Hugo RAS system at...

Analysis

This announcement highlights Medtronic’s first U.S. commercial procedure with the Hugo RAS system at Cleveland Clinic, reinforcing its strategy in robotic-assisted surgery alongside recent spine and cardiovascular innovations. The system’s modular, mobile design and use in more than 35 countries underscore a broad rollout. Historically, similar product and approval milestones have not always driven large price moves, so investors may focus on concrete adoption metrics, indication expansion into gynecologic and general surgery, and integration with Medtronic’s digital operating room offerings.

Key Terms

robotic-assisted surgery, investigational device exemption (ide), laparoscopic

3 terms

robotic-assisted surgery medical

"first U.S. commercial surgical case using its recently FDA-cleared Hugo™ robotic-assisted surgery (RAS) system"

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.

investigational device exemption (ide) regulatory

"part of the Expand URO Investigational Device Exemption (IDE) clinical study — the largest ever"

An investigational device exemption (IDE) is a regulatory permission that allows a medical device to be used in clinical studies so companies can gather safety and effectiveness data before full market approval. For investors, an IDE is a key milestone because it lets a company test real-world performance and move toward commercial clearance or approval—much like a trial run that, if successful, can unlock larger revenue opportunities and reduce regulatory risk.

laparoscopic medical

"Safety, efficacy, and cost effectiveness of common laparoscopic procedures."

Laparoscopic describes a type of minimally invasive surgery performed through small incisions using a tiny camera and long instruments rather than a large open cut; the surgeon watches the procedure on a video screen while operating through those small ports. Investors care because it changes equipment and supply needs, shortens hospital stays and recovery times, and can influence procedure volumes, reimbursement rates and device-adoption trends — like repairing something through a keyhole instead of opening the whole door.

AI-generated analysis. Not financial advice.

Newly FDA-cleared system helps expand patient access to minimally invasive surgery

Cleveland Clinic joins nationally recognized academic medical centers including Atrium Health Wake Forest Baptist High Point Medical Center as first hospitals in the U.S. to install Hugo RAS system

GALWAY, Ireland, Feb. 17, 2026 /PRNewswire/ -- Medtronic today announced that the first U.S. commercial surgical case using its recently FDA-cleared Hugo™ robotic-assisted surgery (RAS) system has been successfully performed by Jihad Kaouk, MD, professor and chair of the Glickman Urologic Institute and the Zegarac-Pollock Endowed Chair in Robotic Surgery at Cleveland Clinic.

Dr. Kaouk successfully completed a robotic-assisted prostatectomy, and the patient was discharged the day after surgery.

"This case exemplifies Cleveland Clinic's mission to lead surgical innovation and expand access to minimally invasive surgery," said Dr. Kaouk. "The new technology allows us to customize the approach for each patient case."

Urology has led the way in adoption of robotic technology, with about 80% of urologic abdominal surgeries in the U.S. today conducted with the assistance of a robotic system. This high adoption rate has created a community of surgeons highly experienced in robotic-assisted procedures available to support training as new technology like the Hugo RAS system becomes available, which is important as robotic-assisted approaches are increasingly common across many specialties and hospitals are looking for solutions to address capacity challenges.

The Hugo RAS system's mobile footprint with modular arms may help address operating room scheduling challenges and infrastructure limitations, enabling more patients access to the well-documented benefits of minimally invasive care — including reduced blood loss, shorter hospital stays, decreased recovery time, and less postoperative pain.^†,1-3

Cleveland Clinic actively researches and implements new robotic approaches. Their team, led by Dr. Kaouk as the Principal Investigator, was part of the Expand URO Investigational Device Exemption (IDE) clinical study — the largest ever completed for multi-port robotic-assisted urological surgery in the U.S. Expand URO demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints in urologic surgical procedures, with outcomes that are consistent with published literature.

"We are excited that the first commercial case in the U.S. using the Hugo RAS system has been successfully completed by Dr. Kaouk and his team. Their pioneering spirit and collaboration reflect our shared vision that with new technology, like Hugo, more patients can access the benefits of minimally invasive surgery," said Rajit Kamal, vice president and general manager of Robotic Surgical Technologies within the Surgical business of Medtronic. "The future of surgery isn't about robotics as a separate modality, it's about technology that enables surgical teams to deliver the best possible care for every patient. Medtronic is uniquely positioned to do that as the only company in the world that can partner with surgeons and hospitals across open, laparoscopic, and robotic-assisted surgery."

In addition to Cleveland Clinic, Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first hospitals in the U.S. to install the Hugo RAS system. Atrium Health Wake Forest Baptist High Point Medical Center is the first hospital in the country to install the Hugo RAS system that was not part of the IDE clinical study.

The Hugo RAS system represents an advancement in surgical robotics in the U.S., offering surgeons a flexible, accessible alternative that prioritizes choice, collaboration, and efficiency in the operating room. The Hugo RAS system is available for use in more than 35 countries around the world. The introduction of the Hugo RAS system in the U.S. builds on Medtronic's broad surgical offering, including the Touch Surgery™ ecosystem, to deliver a connected, integrated operating room — today and in the future.

The company plans to follow its initial urology indication for the Hugo™ RAS system with indication expansion into gynecologic and general surgery procedures, including hernia repair.

For more information, visit medtronic.com/hugoishere.

†Compared to open surgery.

1. Fitch K, Engel T, Bochner A. Cost differences between open and minimally invasive surgery. Managed Care. 2015;24(9):40–48.
2. 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.
3. 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.

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

What happened in Medtronic (MDT) Hugo RAS first U.S. surgery on Feb. 17, 2026?

Medtronic completed the first U.S. commercial Hugo RAS surgical case on Feb. 17, 2026. According to the company, Cleveland Clinic performed a robotic-assisted prostatectomy and the patient was discharged the day after surgery.

Is the Hugo RAS system FDA-cleared for use by Medtronic (MDT) in the U.S.?

Yes — the Hugo RAS system is FDA-cleared for its initial indication in urology in the U.S. According to the company, the system entered commercial use after meeting primary IDE safety and effectiveness endpoints.

What did the Expand URO IDE study show about Hugo RAS, per Medtronic (MDT)?

The Expand URO IDE study met primary safety and effectiveness endpoints for multi-port urologic surgery. According to the company, outcomes were consistent with published literature and supported U.S. commercial use.

Which U.S. hospitals installed Hugo RAS early, and where was MDT's first case performed?

Cleveland Clinic performed Medtronic's first U.S. commercial case; Duke University Hospital and Atrium Health Wake Forest Baptist High Point also installed Hugo. According to the company, Atrium Health Wake Forest Baptist High Point was first outside the IDE study to install Hugo.

Will Medtronic (MDT) expand Hugo RAS beyond urology, and what is the timeline?

Medtronic plans to expand Hugo RAS indications into gynecologic and general surgery, including hernia repair. According to the company, these are planned follow-on indications but no specific approval timelines were provided in the announcement.