Cleveland Clinic, the first hospital in the US to perform robot-assisted prostate surgery with a newly FDA-approved system
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- Cleveland Clinic became the first health system in the United States to perform a prostatectomy with a new robotic surgery system approved by the FDA in December 2025.
Cleveland Clinic. Following approval by the US Food and Drug Administration (FDA) in December 2025, Cleveland Clinic became the first health system in the United States to use a new robot-assisted surgery system to perform a prostatectomy.
The new robotic system has modular “arms” that allow the surgeon to choose the best angle during the operation, as well as an open console where the surgeon sits to operate the pedals and hand controls. This allows the surgeon to concentrate fully on the surgery while remaining aware of their surroundings.
The benefits of minimally invasive robotic surgery include less blood loss, shorter hospital stays, shorter recovery times and less postoperative pain for patients.
FDA approval was based on data from the Expand URO investigational device exemption clinical study, the largest ever conducted in the United States for multi-port robot-assisted urological surgery. The study was led by Dr Jihad Kaouk, who served as principal investigator. Expand URO showed that the system, called Hugo RAS, met the main safety and efficacy criteria in urological surgical procedures.
“This case exemplifies Cleveland Clinic’s mission to lead surgical innovation and widen access to minimally invasive surgery for patients,” said Dr Jihad Kaouk, professor and chair of the Glickman Urological Institute and holder of the Zegarac-Pollock Chair in Robotic Surgery.
“The potential of this new technology extends beyond urology into other specialities, and we look forward to continuing to build our experience with this new system and exploring the additional benefits for patients.”
About Cleveland Clinic
Cleveland Clinic is a non-profit multispecialty academic medical centre that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care built on the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S. News & World Report consistently names Cleveland Clinic as one of the nation’s best hospitals in its annual “America’s Best Hospitals” survey. Among Cleveland Clinic’s 70,800 employees worldwide are more than 4,660 salaried physicians and researchers, and 18,500 registered nurses and advanced practice providers, representing 140 medical specialities and subspecialities. Cleveland Clinic is a 6,500-bed health system that includes a 173-acre main campus near downtown Cleveland, 19 hospitals, more than 220 outpatient centres and locations in southeast Florida; Las Vegas, Nevada; Toronto, Canada; Abu Dhabi, United Arab Emirates; and London, England. In 2020, there were a total of 8.7 million outpatient visits, 273,000 hospital admissions and observations and 217,000 surgical cases across the Cleveland Clinic health system. Patients came for treatment from every state and 185 countries.