FDA clears Medtronic Stealth AXiS for cranial and ENT procedures with AI-powered automatic tractography

Medtronic/Stealth AXiS surgical system

FDA cleared Stealth AXiS for cranial and ENT (ear, nose, throat) procedures, expanding the platform beyond spine surgery. The system includes AI-powered automatic tractography that generates patient-specific brain maps showing critical neural pathways, integrated GE HealthCare intraoperative ultrasound, and real-time motion tracking.

• Expanded FDA clearance covers cranial and ENT procedures; spine clearance granted February 2026.
• AI-based automatic tractography creates patient-specific brain maps showing neural pathways critical to essential functions.
• Integrated intraoperative ultrasound from GE HealthCare provides additional real-time imaging during procedures.
• Unifies surgical planning, real-time navigation and robotic-assisted placement for complex neurosurgical and ENT cases.