Cleveland Clinic has become the first health system in the U.S. to perform a prostatectomy using a newly approved robotic-assisted surgery platform. After receiving clearance from the FDA in December 2025, the system introduces modular robotic arms that allow surgeons to optimize positioning and angles during procedures, along with an open-console design that enables the surgeon to operate hand controls and foot pedals while seated.

Minimally invasive robotic surgery is associated with several patient benefits, including reduced blood loss, shorter hospital stays, faster recovery times and less postoperative pain.

The FDA’s decision was supported by findings from the Expand URO investigational device exemption (IDE) clinical trial, which was the largest U.S. study to date evaluating multi-port robotic-assisted urologic surgery. The study showed that the Hugo RAS system by Medtronic met its primary safety and effectiveness endpoints in urologic procedures.

“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,” said Dr. Jihad Kaouk, professor and chair of the Glickman Urologic Institute and Zegarac-Pollock Endowed Chair in Robotic Surgery.