Medtronic Secures Breakthrough Status for Stealth AXiS™ Integrated Spine Surgery Platform

Medtronic has received U.S. Food and Drug Administration (FDA) clearance for the Stealth AXiS™ surgical system, a next-generation platform that integrates planning, navigation, and robotics into a single system for spine surgery.

The system is cleared for spine procedures in the United States, with an architecture designed to support future cranial and ENT applications pending additional clearance. 

It is suitable for a wide range of clinical complexities and care settings, allowing hospitals and ambulatory surgery centres to use one integrated platform instead of multiple standalone systems.

A key feature is LiveAlign™ segmental tracking, which provides real-time visualisation of spinal motion, surgical adjustments, and patient alignment during procedures. 

This reduces reliance on repeated imaging and manual steps, supporting more consistent execution of patient-specific surgical plans.

As part of Medtronic’s AiBLE™ smart ecosystem, the Stealth AXiS™ system enables seamless information flow across the surgical continuum, connecting devices, software, and data to streamline workflows before, during, and after surgery.

The clearance reflects Medtronic’s focus on building durable, flexible platforms that simplify complex surgical procedures today while enabling future expansion across procedures, specialties, and care settings.