FDA clears new robotic surgery system, expanding options for prostate and kidney procedures

Viviana Cetola
5 hours ago
4 min read

https://www.youtube.com/watch?v=wATujZfErA4

By Viviana Cetola

Reporter, Life News Today

Patients who may need surgery for prostate cancer, kidney disease or bladder conditions could soon see another robotic option available at hospitals across the United States. The United States Food and Drug Administration (FDA) has cleared Medtronic’s Hugo robotic assisted surgery system for certain urologic procedures, meaning the company can now market the device nationwide for those specific surgeries. For consumers, this matters because the type of technology a hospital uses can influence how a procedure is performed, how many surgical options are available locally and what choices are discussed between a patient and their doctor. While the clearance does not change the medical condition itself or guarantee a different outcome, it does mean hospitals may have another FDA reviewed robotic system to consider when planning surgical care.

According to the FDA’s public 510(k) database, the Hugo system was cleared under premarket notification number K250725 on Dec. 3, 2025. The 510(k) process is one of the main ways medical devices are authorized in the United States. Under this pathway, the FDA reviews data submitted by a company and determines whether the device is substantially equivalent in safety and effectiveness to another legally marketed device already in use for the same intended purpose. Clearance under 510(k) allows the product to be sold for the approved uses but does not mean it is better than other available options.

Medtronic announced in December 2025 that the clearance covers minimally invasive procedures involving the prostate, kidneys and bladder, including prostatectomy, nephrectomy and cystectomy. The company estimates these procedures account for about 230,000 surgeries each year in the United States. The FDA authorization applies only to those specific urologic procedures and does not approve the system for other types of surgery.

The Hugo system enters a U.S. market in which Intuitive Surgical’s da Vinci robotic platform has been widely used in hospitals for more than 20 years. Public financial filings and industry reporting describe da Vinci as having a large installed base across several specialties. The clearance of another robotic system means hospitals evaluating new equipment or expanding surgical programs may have an additional option to compare in terms of cost, training and workflow.

In robotic assisted surgery, the physician remains in control throughout the operation. The surgeon sits at a console near the patient and uses hand controls to guide robotic arms equipped with small surgical instruments. The system translates the surgeon’s hand movements into very precise movements inside the body through small incisions. The robot does not operate on its own and does not make medical decisions. Minimally invasive procedures are commonly associated with smaller incisions than traditional open surgery and, depending on the case, may be linked to less blood loss and shorter hospital stays. Results can vary based on the patient’s overall health, the complexity of the condition and the experience of the surgical team.

The FDA’s decision was supported in part by data from the Expand URO study, conducted in the United States under an Investigational Device Exemption. According to Medtronic and publicly available conference materials, the multicenter study enrolled 137 patients undergoing urologic procedures and met its primary safety and effectiveness endpoints. The study is listed on ClinicalTrials.gov under identifier NCT05696444. The FDA’s clearance reflects review of data submitted to demonstrate that the system performs comparably to previously cleared devices for the same uses.

Medtronic says the Hugo system uses a modular design with independent robotic arm carts that can be positioned separately around the operating table. The company also describes integration with its Touch Surgery digital platform for training and workflow support. These descriptions are based on company disclosures associated with the FDA clearance.

Cost is one factor hospitals consider when deciding whether to adopt new surgical technology. Public reporting and hospital financial disclosures indicate that surgical robotic systems can require multimillion dollar investments, along with ongoing expenses for maintenance contracts, specialized instruments and staff training. Hospitals typically evaluate whether their surgical volume and infrastructure can support such investments before purchasing new systems.

Insurance coverage generally relates to the surgical procedure itself rather than the specific brand of equipment used. Coverage policies vary by insurer and plan, but Medicare and many private insurers typically cover medically necessary procedures such as prostatectomy, nephrectomy and cystectomy when consistent with accepted standards of care. Robotic assistance is generally considered part of how the surgery is performed rather than a separately reimbursed service. Patients should confirm coverage details, preauthorization requirements and potential out of pocket costs with their insurer and medical provider before scheduling surgery.

In addition to FDA oversight of medical device safety and effectiveness, the Federal Communications Commission (FCC) regulates the use of radiofrequency spectrum for wireless technologies. The FDA states that it coordinates with the FCC on issues involving wireless enabled medical devices, such as electromagnetic compatibility and spectrum use. FCC oversight does not involve reviewing surgical performance or clinical outcomes.

The Hugo clearance is limited to the defined urologic procedures reviewed by the FDA. Any expansion into other specialties would require additional regulatory submissions and further FDA review before the system could be marketed for those uses. Patients who are considering surgery may wish to discuss with their physician whether a minimally invasive robotic approach is appropriate for their specific condition and what experience the surgical team has with the available system.