Business
Medtronic Receives FDA Clearance for Stealth AXiS™ Surgical System for Cranial and ENT Procedures
Medtronic (NYSE: MDT), a global leader in healthcare technology, today 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 reinfor
About this update from Medtronic Plc.
[{"type":"text","content":"GALWAY, Ireland, March 27, 2026 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in healthcare technology, today 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.","length":687,"tagName":"p"},{"type":"text","content":""Cranial procedures require an exceptional level of precision, planning, and real-time insight," said Michael Carter, Senior Vice President and President of Medtronic Cranial & Spinal Technologies. "With the Stealth AXiS™ surgical system, we are bringing together advanced navigation, robotics, and AI-enabled capabilities within the AiBLE™ smart ecosystem to support surgeons with deeper insights across the surgical workflow."","length":452,"tagName":"p"},{"type":"text","content":"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.","length":520,"tagName":"p"},{"type":"text","content":""For complex brain surgeries, the more information you have, the better decisions you can make," said Dr. Michael Ivan, neurosurgeon at the University of Miami Health System. "Pre-operative planning with tools like tractography may help surgeons enhance surgical efficiency and support better patient outcomes." 1,2","length":335,"tagName":"p"},{"type":"text","content":"For ENT procedures, the Stealth AXiS™ surgical system delivers high-precision navigation and advanced visualization tailored to the intricate anatomy of...