Medtronic has received FDA clearance for the Stealth AXiS surgical system for use in cranial and ear, nose, and throat procedures, expanding the platform beyond its initial spine surgery clearance granted in February. The system combines surgical planning, navigation, and robotics capabilities in a unified platform powered by AI-enabled architecture.
Key features include automatic tractography for generating patient-specific brain maps and visualizing critical neural pathways, along with integration of intraoperative ultrasound through GE HealthCare’s bkActiv system for real-time imaging. For ENT applications, the platform provides high-precision navigation and advanced visualization customized for sinus and skull base anatomy.
Michael Carter, Senior Vice President and President of Medtronic Cranial and Spinal Technologies, said the company is “bringing together advanced navigation, robotics, and AI-enabled capabilities within the AiBLE smart ecosystem.” The flexible architecture is designed to support continuous software innovation and ecosystem connectivity across surgical disciplines.