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Feb 13, 2026 12:01 PM

Medtronic Wins FDA Nod For Spine Surgery Tech Designed To Cut Repeat Imaging

On Friday, the U.S. Food and Drug Administration cleared Medtronic plc’s (NYSE:MDT) Stealth AXiS surgical system 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.

Built to support a wide range of surgeon preferences, clinical complexity, and care settings, the platform is designed for use across hospitals and ambulatory surgery centers without relying on multiple standalone technologies.

Spine Surgery System

The Stealth AXiS system is built to support a variety of surgical preferences and complexities, allowing for real-time visibility into anatomical motion during procedures.

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 ...