Medtronic Gains FDA Clearance for Stealth AXiS with LiveAlign Tracking
The U.S. FDA cleared Medtronic’s Stealth AXiS surgical system for U.S. spine procedures, enabling real-time LiveAlign segmental tracking to reduce repeat imaging. The platform integrates planning, navigation and robotics across hospitals and ambulatory surgery centers and is architected to support future cranial and ENT applications.
1. FDA Clearance and Indications
Medtronic’s Stealth AXiS system received FDA 510(k) clearance for use in spine surgeries in the United States. This approval confirms the device meets safety and performance standards for spine applications without requiring repeated intraoperative imaging.
2. LiveAlign Segmental Tracking Innovation
The system’s LiveAlign segmental tracking offers surgeons real-time visualization of anatomical motion, surgical adjustments and patient alignment, reducing manual steps and workflow interruptions during spine procedures.
3. Integrated Platform for Diverse Care Settings
Stealth AXiS combines planning, navigation and robotic guidance into a single platform designed for both hospitals and ambulatory surgery centers, enabling consistency of surgeon preferences and clinical complexity handling.
4. Future Expansion into Cranial and ENT
Built on an open architecture, the platform is positioned for upcoming 510(k) clearances in cranial and ENT applications, aiming to leverage the same integrated planning and navigation capabilities across new surgical specialties.