Medtronic’s Stealth AXiS Robot Earns CE Mark for ENT Surgery

Medtronic has earned CE mark approval for the Stealth AXiS surgical system for ear, nose, and throat (ENT) procedures. The EU nod brings advanced visualization, navigation, and connected workflow capabilities to ENT surgeons and hospitals in Europe.

The Stealth AXiS system was built around real-world ENT workflows and is designed to support navigation of basic to complex anatomy of the sinuses and skull base. It provides enhanced anatomical visualization and faster responsiveness compared to previous-generation platforms, according to Medtronic.

“Receiving CE mark for the Stealth AXiS surgical system in ENT procedures is an important milestone for ENT surgeons and patients across Europe,” said Sean Haag, president of the Ear, Nose, & Throat business at Medtronic. “This platform builds on our long legacy in surgical navigation while introducing a more connected, intelligent system specifically designed for the future of ENT surgery.”

The system supports a range of ENT procedures, including minimally invasive sinus and skull base surgery as well as sinus balloon procedures. The platform integrates into the company’s AiBLE ENT smart ecosystem, which helps connect technologies and workflows across the ENT surgical experience.

“We’re excited to reach this milestone and expand access to the Stealth AXiS surgical system across Europe,” said Panos Drakoulas, VP of international for the Ear, Nose, and Throat business at Medtronic. “ENT surgeons are looking for technology that fits naturally into their workflow while helping them navigate basic to highly complex anatomy with confidence. The Stealth AXiS surgical system was built with those insights in mind, and we look forward to supporting more surgeons and patients across the region.”

The CE mark follows recent U.S. Food and Drug Administration (FDA) clearance for ENT procedures earlier this year. Stealth AXiS also received CE mark certification for spine and cranial procedures.