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Dec 4, 2025 12:00 PM

Medtronic Scores FDA Win As Hugo Surgical Robot Enters 230,000 Urology Procedure Market

On Wednesday, the U.S. Food and Drug Administration (FDA) cleared Medtronic Plc’s (NYSE:MDT) Hugo robotic-assisted surgery (RAS) system for use in urologic surgical procedures.

MDT is in positive territory. See the full story here.

The Hugo RAS system’s clearance brings a versatile robotic-assisted platform to U.S. surgeons and health systems seeking to expand soft-tissue robotic surgery programs and access to minimally invasive care.

With FDA clearance, the Hugo RAS system is indicated for use in minimally invasive urologic surgical procedures.

The procedures include prostatectomy, nephrectomy, and cystectomy,  common procedures that account for about 230,000 surgeries per year in the U.S.

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The Expand URO investigational device exemption clinical study demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints ...