Medtronic’s FDA Cleared Stealth AXiS Spine System Cuts Repeat Imaging
FDA cleared Medtronic’s Stealth AXiS system for US spine surgery, adding LiveAlign segmental tracking to visualize anatomical motion in real time and cut repeat imaging. The integrated platform supports hospitals and ambulatory surgery centers and is architected for future cranial and ENT applications pending 510(k) clearance.
1. FDA Clearance Granted
Medtronic announced that the FDA granted 510(k) clearance for the Stealth AXiS surgical system for spine surgery on February 13, marking its first integrated navigation and planning platform approved in the US market.
2. Innovative LiveAlign Technology
The system features LiveAlign segmental tracking, which delivers real-time visualization of anatomical motion and patient alignment during spine procedures, eliminating the need for repeated intraoperative imaging and manual workflow steps.
3. Market Deployment and Growth Potential
Designed for use in both hospitals and ambulatory surgery centers, the Stealth AXiS platform’s flexible architecture supports future cranial and ENT applications pending separate clearances, positioning Medtronic to expand its surgical navigation portfolio and drive long-term revenue growth.