Medtronic’s Stealth AXiS Spine Platform Secures FDA Approval with LiveAlign Tracking
Medtronic’s Stealth AXiS surgical system received FDA clearance for spine procedures in the U.S., featuring LiveAlign segmental tracking to visualize anatomic motion in real time and eliminate repeated imaging steps. The platform’s integrated architecture supports hospitals and ambulatory surgery centers and is designed for future cranial and ENT applications.
1. FDA Clearance for Stealth AXiS
On February 13, the FDA granted 510(k) clearance for Medtronic’s Stealth AXiS system to perform spine surgery in the United States. The cleared platform is built on an integrated architecture that will also support planned future indications in cranial and ear, nose and throat procedures pending additional regulatory approvals.
2. LiveAlign Segmental Tracking Feature
Stealth AXiS incorporates LiveAlign segmental tracking, enabling surgeons to monitor anatomic motion, surgical adjustments and patient alignment in real time during spine operations. This innovation reduces dependence on repeat imaging and manual workflow steps, aiming to enhance procedural consistency and efficiency.
3. Market Deployment and Outlook
The system is designed for use across hospitals and ambulatory surgery centers without requiring multiple standalone technologies. With a broad surgeon preference footprint and support for complex clinical settings, Stealth AXiS is positioned to drive Medtronic’s spine surgery revenue and lay groundwork for expansion into other surgical specialties.