Healthcare technology company Medtronic (NYSE: MDT) reported on Wednesday that it has submitted multiple 510(k) applications to the U.S. Food and Drug Administration aimed at expanding the clinical use of its Hugo robotic-assisted surgery system, including proposed indications for general surgery, hernia repair and gynecologic procedures.

The company also filed a 510(k) submission for the LigaSure RAS Maryland instrument, designed exclusively for use with the Hugo platform and Valleylab FT10 energy system, while announcing FDA clearance for the ProGrip Advanced self-gripping polypropylene mesh for robotic-assisted ventral hernia repair.

These regulatory milestones build on Hugo's FDA clearance for urologic procedures received in December 2025. The system is currently in use at US medical centres and has been deployed in tens of thousands of procedures across more than 35 countries.

Medtronic said the expanded indications would significantly broaden Hugo's addressable market in high-volume surgical specialties, where demand for minimally invasive robotic-assisted procedures continues to grow. The company also completed patient enrolment in its Embrace Gynecology Investigational Device Exemption study, a multicentre US trial evaluating the safety and effectiveness of Hugo in robotic-assisted gynecologic surgery. The study enrolled 70 patients across five hospitals.

The newly cleared ProGrip Advanced mesh is designed specifically for robotic-assisted ventral hernia repair, a market encompassing nearly 470,000 procedures annually in the United States. Medtronic said the product enhances handling, deployment and surgical efficiency during robotic procedures.

Medtronic's surgical portfolio is further strengthened as the company expands its ecosystem across open, laparoscopic and robotic-assisted surgery and seeks broader adoption of the Hugo platform in the US.