Medtronic today announced FDA clearance of the Stealth AXiS surgical system, a platform that combines planning, navigation, and robotics for spine surgery.
The Stealth AXiS system is cleared for spine procedures in the United States, with an underlying architecture designed to support future cranial and ENT applications, pending 510(k) clearance.
Medtronic said a key innovation of the Stealth AXiS system is LiveAlign segmental tracking, a capability that allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spine surgery, without the need for repeated imaging.
"Spine surgery is complex, and variability remains a real challenge," said Michael Carter, Senior Vice President and President of Medtronic Cranial & Spinal Technologies. "The Stealth AXiS system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalized care while laying the foundation for continued innovation."
