Medtronic announced that the U.S. Food and Drug Administration has cleared its Hugo robotic‑assisted surgery (RAS) system for use in minimally invasive urologic procedures, including prostatectomy, nephrectomy and cystectomy. The clearance, effective immediately, gives Medtronic a foothold in a market that performs roughly 230,000 urologic surgeries each year in the United States, a segment that has historically been dominated by Intuitive Surgical’s da Vinci platform.
The approval follows the successful Expand URO investigational device exemption study, in which the Hugo RAS system met all primary safety and effectiveness endpoints. The study reported a 98.5% surgical success rate, and a separate Enable Hernia Repair trial documented a 100% success rate in hernia repair procedures. These data demonstrate the system’s clinical reliability across a range of procedures and support its broader adoption.
Medtronic’s Hugo RAS system has already been deployed in more than 30 countries for urologic, gynecologic and general surgery. In the United States, the system is priced between $1.2 million and $1.5 million, roughly 50–60% lower than the da Vinci system’s $2.5 million price point. The company plans to begin commercial sales in the U.S. within the next 90 days, with an initial target of 200 units in the first year and a projected market share of 10–12% of the urologic robotics market by 2027.
Chief Executive Officer Geoff Martha said the clearance “provides hospitals with a new, cost‑effective option for robotic surgery and expands access for patients.” Rajit Kamal, VP and GM of Robotic Surgical Technologies, added that the FDA approval “creates a foundation for Medtronic to expand the Hugo RAS system into general and gynecologic surgery in the U.S. in the coming years.” The company’s broader strategy is to offer a single platform that supports open, laparoscopic and robotic approaches, positioning Medtronic as a one‑stop surgical solutions provider.
The clearance is expected to accelerate Medtronic’s growth in the surgical robotics segment, which has been a key focus of the company’s 2025 guidance. With the U.S. market now accessible, Medtronic can leverage its existing Touch Surgery ecosystem—providing training, remote proctoring and AI‑powered post‑operative insights—to differentiate the Hugo RAS system and drive adoption. The lower price point and modular, portable design are likely to appeal to hospitals seeking to increase utilization and reduce capital outlay, potentially shifting market share away from Intuitive and strengthening Medtronic’s competitive position in the high‑margin urologic robotics space.
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