Medtronic Wins FDA Clearance for Stealth AXiS Spine Surgery System

Medtronic has received clearance from the U.S. Food and Drug Administration for its next-generation Stealth AXiS spine surgery system, which integrates AI-based planning, real-time navigation and robotic assistance. The modular platform is designed for use in hospitals and ambulatory surgery centers, offering flexibility to accommodate surgeon preferences.

Stealth AXiS builds on robotics capabilities gained through Medtronic’s 2018 acquisition of Mazor Robotics and incorporates the company’s StealthStation navigation technology. It also connects with Medtronic’s AiBLE ecosystem to support personalized surgical planning, execution and post-operative analysis. The system enables real-time visualization of anatomy and alignment without repeated imaging.

Competitors include Johnson & Johnson, Globus Medical and Stryker. Medtronic has also partnered with Siemens Healthineers to integrate imaging capabilities.

28-02-2026