March 27, 2026- Medtronic announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system for cranial and ear, nose, and throat (ENT) procedures. Cleared for spine procedures in February, the Stealth AXiS™ surgical system unifies surgical planning, navigation, and robotics into a single intelligent system to support surgeons with greater precision and real-time insights during complex procedures. This clearance reinforces Medtronic’s strategy to deliver connected technologies that support surgeons across multiple specialties on a single platform.
A defining capability of the platform is its AI-enabled architecture, which supports advanced planning and visualization before, during, and after surgery. For cranial procedures, the system includes AI-based automatic tractography that helps surgeons generate patient-specific brain maps and visualize critical neural pathway associated with essential brain functions. The platform also integrates intraoperative ultrasound through GE HealthCare’s bkActiv™, providing additional real-time imaging during procedures.