Medtronic’s Stealth AXiS Surgical System Gains CE Mark

Medtronic has received CE mark clearance for its Stealth AXiS surgical system, a next-gen platform that merges planning, navigation, and robotics in one intelligent system.

The system is indicated for spine and cranial procedures. It’s designed to support a range of clinical workflows and surgical environments, enabling hospitals to adopt capabilities based on their needs while keeping flexibility for future expansion.

The system’s LiveAlign segmental tracking is and industry-first capability, according to Medtronic. It allows surgeons to visualize anatomical motion and patient alignment in real-time during spine procedures. It’s a cornerstone of Medtronic’s AiBLE ecosystem and connects pre-, intra-, and post-op workflows for a more integrated approach to surgical care.

In cranial applications, Stealth AXiS boasts artificial intelligence (AI)-powered automatic tractography so surgeons can create patient-specific brain maps and clearly visualize critical neural pathways linked to essential brain functions.

“The introduction of the Stealth AXiS system to Europe reflects our focus on delivering connected platforms that improve precision, efficiency, and consistency across diverse healthcare systems,” said Michael Carter, senior VP and president of Cranial & Spinal Technologies at Medtronic. “By bringing planning, navigation, and robotic guidance into a unified workflow, we are helping surgeons translate insight into action in the operating room, supporting more predictable and personalized care while building a strong foundation for continued innovation.”

This CE mark follows U.S. Food and Drug Administration (FDA) clearances earlier this year.