WEBULL

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

Benzinga · 1d ago

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.

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.

Also Read: This Medical Device Maker Is Seeing High Demand In Cardiovascular, Diabetes Business

The Expand URO investigational device exemption clinical study demonstrated that the Hugo RAS system met primary safety and effectiveness endpoints in urologic surgical procedures, with outcomes that are consistent with published literature.

Outside the U.S., the Hugo RAS system has been used in several urologic, gynecologic, and general surgery procedures in more than 30 countries.

Medtronic intends to expand the Hugo RAS system’s use in the U.S. to additional surgical specialties over time, with indications for general and gynecologic surgical procedures expected to follow the initial urology clearance.

In September, Medtronic released results from the Enable Hernia Repair clinical study evaluating the performance of the Hugo RAS system in inguinal and ventral hernia repair procedures.

Primary safety and effectiveness endpoints were met. Key findings included that the surgical success rate was 100%, surpassing the pre-specified performance goal of 85%.

Analyst Take

William Blair notes that the company has not provided any details on the anticipated launch timing, but the analyst Brandon Vazquez expects U.S. sales should begin to contribute in the latter part of fiscal 2026 with a more material impact in fiscal 2027.

“For Medtronic, this, of course, is a positive, as this has been a long-awaited release and should provide the company with a tailwind going into next calendar year. We are believers that physicians prefer more, rather than fewer, options in choosing therapy, so we expect there will be some interest in the Hugo system despite the strong competitive moat from Intuitive (NASDAQ:ISRG),” William Blair wrote on Thursday.

MDT Price Action: Medtronic shares were up 0.26% at $102.24 at the time of publication on Thursday, according to Benzinga Pro data.

Read Next:

Photo by JHVEPhoto via Shutterstock