Medtronic Advances Towards U.S. Launch of Hugo Robotic Surgery System

Published 7 hours agoMDT

Medtronic Advances Towards U.S. Launch of Hugo Robotic Surgery System

Medtronic is progressing toward a pivotal U.S. market entry for its Hugo robotic-assisted surgery (RAS) system. The company plans to submit the system for FDA approval by early 2025, specifically targeting urology indications, with an anticipated U.S. launch in the fiscal year 2026, as reported by MassDevice.

As part of its strategy, Medtronic has initiated clinical studies in the U.S. for hernia and gynecology procedures to further support its upcoming FDA submissions, according to a recent announcement on the company's news portal. The Hugo RAS has already received CE Mark approval in Europe since October 2021, which has permitted its deployment in urologic and gynecologic surgeries there.

Medtronic's strategic moves aim to strengthen its position in the competitive soft tissue robotic surgery market, challenging established players like Intuitive Surgical, known for its dominant da Vinci system. These developments underscore Medtronic's commitment to enhancing its footprint in the robotic surgery arena.

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