Medtronic Secures CE Mark for Stealth AXiS Surgical System

Medtronic has received CE mark approval for its Stealth AXiS surgical system, enabling its use across Europe for spine and cranial procedures. The milestone follows earlier clearance from the U.S. Food and Drug Administration, which approved the system for spine surgeries in February and expanded its use to cranial and ENT procedures in March.

The Stealth AXiS platform integrates surgical planning, navigation, and robotics—building on capabilities gained through Medtronic’s acquisition of Mazor Robotics. It also incorporates intraoperative ultrasound technology from GE HealthCare, allowing real-time imaging during procedures.

The system enables surgeons to visualise anatomical changes, patient alignment, and surgical adjustments in real time, reducing the need for repeated imaging. In cranial applications, it features AI-enabled tractography to support brain mapping and decision-making.

With CE mark certification under EU regulations, Medtronic is now positioned to expand into international markets and strengthen its presence in the global cranial and spinal technologies segment.

04-05-2026