Medtronic Hugo Robotic Surgery System Receives FDA Clearance and Completes First US Case
The FDA cleared the Hugo robotic-assisted surgery system for urologic procedures on December 3, 2025. On February 17, 2026, the first US commercial case — a robotic prostatectomy — was completed at Cleveland Clinic.
The Story at a Glance:
- The Medtronic Hugo robotic surgery system received FDA clearance on December 3, 2025, for minimally invasive urologic procedures including prostatectomy, nephrectomy, and cystectomy
- The first US commercial case was performed at Cleveland Clinic on February 17, 2026 — a robotic prostatectomy with next-day patient discharge
- Hugo is the first new soft-tissue robotic surgery platform to enter the US market in more than two decades, breaking Intuitive Surgical’s long-standing dominance
- The pivotal Expand URO study showed a 98.5% surgical success rate across 137 patients, and Medtronic plans to pursue additional indications for hernia repair and gynecologic surgery
What Happened
The FDA cleared the Medtronic Hugo robotic surgery system on December 3, 2025, for use in minimally invasive urologic surgical procedures. The clearance covers prostatectomy, nephrectomy, and cystectomy — procedures that collectively account for approximately 230,000 surgeries per year in the United States, according to Medtronic.
On February 17, 2026, Jihad Kaouk, MD, professor and chair of the Glickman Urologic Institute at Cleveland Clinic, performed the first US commercial case using the system — a robotic-assisted prostatectomy. The patient was discharged the day after surgery. Duke University Hospital and Atrium Health Wake Forest Baptist High Point Medical Center are among the first additional hospitals to install the platform, with the latter being the first site outside the original clinical trial to receive the system.
The clearance was supported by the Expand URO investigational device exemption (IDE) study, which Medtronic describes as the largest prospective, multi-center study ever completed for multi-port robotic-assisted urologic surgery in the US. The American Urological Association classified the trial data as a practice-changing study when results were presented at its April 2025 annual meeting.
Why the Medtronic Hugo Robotic Surgery System Matters
Hugo’s arrival marks the first time in more than 20 years that a large medtech company has introduced a soft-tissue robotic surgical platform to the US market. Since Intuitive Surgical launched its da Vinci system, no comparable competitor has achieved FDA clearance for soft-tissue procedures at this scale. About 80% of urologic abdominal surgeries in the US are already performed with robotic assistance, but hospitals continue to face capacity and access challenges.
Medtronic has positioned Hugo as a more flexible and potentially more accessible option, particularly for mid-sized hospitals and community centers that have faced barriers to starting robotic programs. The system’s modular design — with robotic arms on individual wheeled carts rather than a single fixed unit — allows the hardware to be shared across operating rooms and care settings, which may help address scheduling constraints and infrastructure limitations.
Key Details
| Device | Hugo™ Robotic-Assisted Surgery (RAS) System |
|---|---|
| Manufacturer | Medtronic plc (Galway, Ireland) |
| Device Class | Multi-port, modular soft-tissue robotic surgical platform |
| Approved Indication | Minimally invasive urologic surgery: prostatectomy, nephrectomy, cystectomy |
| FDA Clearance Date | December 3, 2025 |
| Regulatory Pathway | 510(k) clearance supported by Expand URO IDE study |
| Pivotal Trial | Expand URO: 137 patients, 11 surgeons, 6 US hospitals; 98.5% surgical success rate (p<0.0001 vs. 85% goal); Grade ≥3 complications: 3.7% prostatectomy, 1.9% nephrectomy, 17.9% cystectomy — all below pre-set thresholds; 1.5% conversion rate |
| First US Commercial Case | February 17, 2026 — robotic prostatectomy at Cleveland Clinic (Dr. Jihad Kaouk) |
| Early Adopter Sites | Cleveland Clinic, Duke University Hospital, Atrium Health Wake Forest Baptist High Point Medical Center |
| Digital Integration | Touch Surgery™ ecosystem: pre-operative training, remote tele-proctoring, AI-powered post-operative case insights |
| Global Availability | 35+ countries, 5 continents; tens of thousands of procedures performed |
| Planned US Expansions | Hernia repair (Enable study endpoints met); gynecologic surgery (Embrace GYN IDE study ongoing) |
What Experts Are Saying
“The new technology allows us to customize the approach for each patient case.”
— Jihad Kaouk, MD, Chair, Glickman Urologic Institute, Cleveland Clinic
Michael R. Abern, MD, the Expand URO study’s national principal investigator and a urologic surgeon at Duke University Cancer Institute, noted that the study demonstrated the Hugo system met its safety and effectiveness endpoints, with outcomes consistent with established robotic surgery literature. Industry analysts at BTIG have observed that while Intuitive Surgical’s da Vinci 5 remains in a strong market position, Medtronic’s scale and ability to bundle Hugo with its broader surgical product portfolio may accelerate placement, particularly through leasing arrangements.
What’s Next
Medtronic is pursuing additional US indications for Hugo beyond urology. The Enable Hernia Repair IDE study has already met its primary safety and effectiveness endpoints, and the company launched the Embrace Gynecology IDE study in October 2025 at AHN West Penn Hospital in Pittsburgh, evaluating the system for total hysterectomy procedures including those for malignancies. No specific timelines for the additional FDA submissions have been disclosed.
The competitive landscape is also evolving. Johnson & Johnson’s Ottava platform — featuring robotic arms integrated directly into the operating table — completed its first US clinical cases in April 2025 and is expected to submit for FDA review in early 2026. Surgeons should anticipate growing options in robotic-assisted surgery over the coming 12 to 18 months as multiple platforms compete for US market share.
The Bigger Picture
Hugo’s US entry represents a shift in the surgical robotics market from a single-platform environment to a multi-system landscape. For more than two decades, hospitals seeking soft-tissue robotic capability have had essentially one option. The introduction of a credible competitor — backed by Medtronic’s existing relationships with surgical departments across open and laparoscopic modalities — could put downward pressure on pricing, expand access to smaller hospitals, and give surgeons more flexibility in choosing platforms suited to their practice. With hernia repair and gynecologic indications on the horizon, the platform’s US footprint is likely to grow substantially through 2026 and 2027.
Bottom Line
- The Medtronic Hugo robotic surgery system is now FDA-cleared for urologic procedures and commercially available in the US, with the first case completed at Cleveland Clinic in February 2026
- The Expand URO IDE study — the largest of its kind — showed a 98.5% surgical success rate and favorable safety outcomes across prostatectomy, nephrectomy, and cystectomy
- Surgeons should monitor indication expansion into hernia repair and gynecologic procedures, as well as competing platform launches from Johnson & Johnson
- Long-term comparative data against established platforms, pricing structures, and real-world utilization outcomes are not yet available
Sources
- Medtronic announces FDA clearance of Hugo™ robotic-assisted surgery system for urologic surgical procedures. Medtronic press release. December 3, 2025. View source
- Medtronic announces first surgery with Hugo™ robotic-assisted surgery system in the U.S. performed at Cleveland Clinic. Medtronic press release. February 17, 2026. View source
- Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo™ robotic-assisted surgery system. Medtronic press release. April 26, 2025. View source
- Abern M, Wiklund P, Goh AC, et al. A prospective, multi-center study assessing effectiveness, safety, and performance of the HUGO robotic-assisted surgery system in the US urologic population: Primary results from the Expand URO IDE study. J Urol. 2025;213(5S2):e4. doi:10.1097/01.JU.0001111604.90306.91.07
- Medtronic initiates U.S. IDE clinical study evaluating Hugo robotic-assisted surgery system for gynecological procedures. Medtronic press release. October 8, 2025. View source
- Medtronic’s Hugo surgical robot earns FDA clearance. MedTech Dive. December 4, 2025. View source