Medtronic Seeks FDA Approval for Hugo Surgical Robot, Aiming to Challenge Intuitive

Medtronic has filed for FDA approval of its Hugo robotic-assisted surgery system for urologic procedures, marking a pivotal move to compete with Intuitive Surgical in the U.S.—the world’s largest robotic surgery market. The submission was made in the first quarter of 2025, following positive data from a study presented at the American Urological Association meeting, where Hugo achieved a 98.5% surgical success rate, surpassing the 85% performance goal.

Hugo, a modular, multi-quadrant platform, is already in use in over 25 countries, but Medtronic has yet to enter the U.S. market, where Intuitive holds a two-decade head start. The FDA decision, expected in the second half of 2025, could make this year a turning point, with new entrants like CMR Surgical also joining the field.

Medtronic has also completed hernia and benign gynecology trial enrollment and received the go-ahead for an oncologic gynecology study, supporting future indication expansions. Hugo is expected to drive surgical business growth starting in fiscal 2026.

08-05-2025