Cleveland Clinic First Hospital in the U.S. To Perform Robotic-Assisted Prostate Surgery Using Newly FDA-Cleared System

Following the recent U.S. Food and Drug Administration’s approval in December 2025, Cleveland Clinic is the first health system in the U.S. to use a new robotic-assisted surgery system for a prostatectomy.

The new robotic system features modular “arms” that allow the surgeon to choose the best angle while operating on the patient, as well as an open console where the surgeon sits to operate the foot pedals and hand controls. This allows the surgeon to focus on the surgery as well as be aware of their surroundings.

The benefits of minimally invasive robotic surgery include reduced blood loss, shorter hospital stays, decreased recovery time and less postoperative pain for patients.

The FDA approval followed data from the Expand URO investigational device exemption clinical study — the largest ever completed for multi-port robotic-assisted urological surgery in the U.S., led by Dr. Jihad Kaouk, who was the principal investigator. Expand URO demonstrated that the system, called the Hugo RAS, met primary safety and effectiveness endpoints in urologic surgical procedures.

“This case exemplifies Cleveland Clinic's mission to lead surgical innovation and expand access to minimally invasive surgery for patients," said Dr. Kaouk, M.D., Professor and Chair, Glickman Urologic Institute and Zegarac-Pollock Endowed Chair in Robotic Surgery. “The potential for this new technology extends beyond urology to other specialties, and we look forward to building our experience with this new system and exploring the added benefit for patients.”