Medtronic receives CE Mark for Stealth AXiS for spine and cranial procedures in Europe

Medtronic/Stealth AXiS surgical system

Medtronic announced CE Mark approval for Stealth AXiS covering spine and cranial procedures, enabling European commercial launch. The system brings integrated surgical planning, real-time navigation tracking and robotic-assisted instrument placement to European surgical centers.

• CE Mark covers spine and cranial procedures; demonstrates scalability across multiple surgical specialties.
• Follows US FDA clearance for spine (February 2026) and cranial/ENT procedures (March 2026).
• Enables European launch and access to the integrated surgical platform outside the US.
• Further CE Mark expected for ENT procedures to complete the product line expansion.