Medtronic’s Stealth AXiS Secures CE Mark for Spine, Cranial Robotics
Medtronic has received CE mark for its Stealth AXiS system, enabling integrated planning, navigation and robotics for spine and cranial surgeries across Europe under EU MDR. The modular platform features LiveAlign segmental tracking for real-time anatomical motion visualization and joins the AiBLE ecosystem after FDA clearances earlier this year.
1. CE Mark Expands European Access
Medtronic has secured CE mark for the Stealth AXiS surgical system under the EU Medical Device Regulation, paving the way for commercial launch across Europe. This regulatory milestone follows U.S. FDA clearances granted earlier this year, underscoring the system’s compliance with stringent safety and performance standards.
2. Integrated Robotics and Modular Design
The Stealth AXiS platform integrates pre-operative planning, real-time navigation and robotic execution into a single, modular system. It is indicated for both spine and cranial procedures, allowing hospitals to customize surgical capabilities and scale the system according to clinical needs.
3. AI Ecosystem and LiveAlign Tracking
A cornerstone feature, LiveAlign segmental tracking, provides surgeons with real-time visualization of patient anatomy and alignment during spine operations. As part of the AiBLE smart ecosystem, the system connects pre-, intra- and post-operative workflows through AI-driven planning and visualization tools.