Medtronic, a global leader in healthcare technology, 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 specialities on a single platform.
"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."
A defining capability of the platform is its AI-enabled architecture, which supports advanced planning and visualisation before, during, and after surgery. For cranial procedures, the system includes AI-based automatic tractography that helps surgeons generate patient-specific brain maps and visualise critical neural pathways associated with essential brain functions. The platform also integrates intraoperative ultrasound through GE HealthCare's bkActiv, providing additional real-time imaging during procedures.
"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."
For ENT procedures, the Stealth AXiS surgical system delivers high-precision navigation and advanced visualisation tailored to the intricate anatomy of the sinuses and skull base. Built around real-world ENT workflows, the system offers sharper anatomical detail and faster responsiveness to support confident decision-making in the OR, as well as intuitive, surgeon-centred workflows to create a familiar user experience while delivering enhanced capabilities.
"Intraoperative navigation is critical in minimally invasive endoscopic surgery of the sinuses and skull base, helping surgeons confidently delineate complex anatomy within high-risk spaces," said Dr Vijay Ramakrishnan, board-certified otolaryngologist and professor of Otolaryngology-Head & Neck Surgery at Indiana University School of Medicine. "The Stealth AXiS system leverages innovative technologies to enhance surgeon workflows and support procedural efficiency and confidence in the operating room."
