Medtronic seeks FDA expansion for Hugo robot, targeting high-volume surgeries

Medtronic submitted 510(k) filings to the FDA to expand the approved uses for its Hugo robotic-assisted surgery (RAS) system. The company seeks new clearance for general surgery, including hernia repair, and gynecologic procedures. The Hugo system has held U.S. clearance for urologic procedures since late 2025.

This expansion into high-volume specialties supports Medtronic's strategy to compete with Intuitive Surgical’s da Vinci system. Medtronic also submitted a 510(k) filing for its LigaSure RAS Maryland instrument.

The company recently received FDA clearance for its ProGrip Advanced mesh for use in robotic-assisted hernia repairs. Medtronic has also completed enrollment for a clinical study evaluating the system's use in gynecology.