Medtronic Earns FDA Clearance for Stealth AXiS Spinal Robot

Medtronic receives FDA clearance for its Stealth AXiS surgical system, the first integrated planning, navigation and robotics platform for spine surgery, featuring LiveAlign real-time tracking.

Medtronic has received U.S. Food and Drug Administration clearance for its Stealth AXiS surgical system, a next-generation platform that brings planning, navigation and robotics together into a single, intelligent system for spine surgery. The clearance, announced February 13, 2026, marks a significant expansion of the company's surgical robotics portfolio following December's FDA nod for its Hugo soft tissue robot.

The Stealth AXiS system introduces LiveAlign segmental tracking, an industry-first capability that allows surgeons to visualize anatomic motion, surgical adjustments and patient alignment in real time during procedures without repeated imaging. This innovation addresses what surgeons describe as one of the biggest challenges in spine surgery: understanding and responding to how the spine moves during an operation.

The platform is designed for use across both hospitals and ambulatory surgery centers without relying on multiple standalone technologies. It combines familiar navigation workflows with a modular robotic design, enabling institutions to deploy what they need today and expand over time as clinical needs evolve.

As a cornerstone of Medtronic's AiBLE smart ecosystem, Stealth AXiS natively integrates planning, navigation and execution within a single platform to streamline workflows and support the exchange of insights before, during and after surgery. The underlying architecture is also designed to support future cranial and ENT applications, pending further 510(k) clearances.

"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."