Medtronic Expands Stealth AXiS System with FDA Clearance for Cranial and ENT Use

Medtronic has received 510(k) clearance from the U.S. Food and Drug Administration for its Stealth AXiS surgical platform in cranial and ear, nose and throat (ENT) procedures. The modular system integrates surgical planning, navigation, and robotics to enhance precision and workflow efficiency in operating rooms.

Initially cleared for spine applications, the platform now supports broader use, enabling neurosurgeons to generate patient-specific brain maps using AI-enabled tractography. For ENT specialists, the system offers advanced visualization tailored to sinus and skull base anatomy, improving navigation in complex, high-risk areas.

Stealth AXiS is also integrated with GE HealthCare’s bkActiv ultrasound system, providing real-time intraoperative imaging. Designed for both hospitals and ambulatory surgery centres, the technology aims to support more informed surgical decisions and improved patient outcomes.

30-03-2026