Medtronic has received U.S. Food and Drug Administration (FDA) clearance for its Stealth AXiS surgical system, a next-gen platform that merges planning, navigation, and robotics into one intelligent system for spine surgery.

Stealth AXiS is cleared for spine procedures in the U.S., with an architecture designed to support future cranial and ENT applications pending 510(k) clearance. The platform is designed for hospitals and ambulatory surgery centers (ASCs) without relying on multiple standalone technologies.

It combines familiar navigation workflows with a modular robotic design so institutions can deploy what they need currently and expand over time as clinical needs evolve.

“The Stealth AXiS system represents a meaningful step forward in how we think about navigation and robotics working together,” said Ronald A. Lehman, Jr., MD, Tenured Professor of Orthopaedic Surgery (Neurological Surgery) at Columbia University, Division Chief of Spine Surgery, and Spine Medical Director at The Spine Hospital at NewYork-Presbyterian/The Allen Hospital, and a paid consultant to Medtronic. “One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure. The Stealth AXiS system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow. To me, this is truly game changing technology.”

Stealth AXiS features LiveAlign segmental tracking, which lets surgeons visualize anatomic motion, surgical adjustments, and patient alignment in real time without needing repeated imaging. The capability helps reduce reliance on manual steps and workflow disruption to support more consistent execution of patient-specific surgical plans, Medtronic said.

The system is a cornerstone of the company’s AiBLE smart ecosystem. Stealth AXiS will help support exchange of insights before, during, and after spine surgery so the broader AiBLE ecosystem can connect devices, software, and data in a more meaningful way.

“Spine surgery is complex, and variability remains a real challenge,” said Michael Carter, senior VP 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.”