February 13, 2026- Medtronic announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system, a next-generation platform that brings planning, navigation, and robotics together into a single, intelligent 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.