Approval in Europe covers spine and cranial procedures for the planning, navigation and robotics platform. It follows back-to-back FDA nods for Stealth AXiS to kick off 2026, first garnering clearance for spine surgery, then getting the green light for cranial and ENT procedures. Medtronic also has a partnership with GE HealthCare to integrate the platform with intraoperative ultrasound technology.
A spine center in Virginia said it became the first in the world to perform surgery using Stealth AXiS last week.
Medtronic designed Stealth AXiS to bring together familiar navigation workflows with a modular robotic design. It allows institutions to deploy what they need and expand over time as needs evolve.
The company built the system on its existing Mazor and StealthStation technologies. A key feature comes in the form of AI-enabled architecture. It supports advanced planning and visualization before, during and after surgery. Stealth AXiS’ LiveAlign segmental tacking allows surgeons to visualize anatomical motion and patient alignment in real time during spine procedures.
In cranial procedures, it features AI-powered automatic tractography. This allows surgeons to create patient-specific brain maps and clearly visualize critical neural pathways linked to essential brain functions.
(Learn more about Medtronic and the surgical robotics space in our MassDevice Surgical Robotics Special Report. Download the report for free here.)
Michael Carter, SVP and president of Medtronic Cranial & Spinal Technologies, spoke to MassDevice recently to outline the benefits of the system.
Commentary from Medtronic officials
Oli Prosperi, VP, International Commercial, Cranial & Spinal Technologies, Medtronic, said:
“Receiving CE mark for the Stealth AXiS system marks an important milestone in expanding access to advanced surgical technologies across Europe. Achieving CE mark in the current regulatory environment, under EU Medical Device Regulation (MDR), underscores our commitment to bringing meaningful innovation into a highly diverse healthcare landscape.”
Carter added:
“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. 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.”
