The platform combines planning, navigation, and robotics, with AI-enabled features for imaging and workflow support.
Medtronic has received US Food and Drug Administration (FDA) clearance for its Stealth AXiS surgical system for use in cranial and ear, nose, and throat (ENT) procedures. The system was previously cleared for spine procedures in February.
The platform integrates surgical planning, navigation, and robotics into a single system intended to support precision and intraoperative decision-making during complex procedures.
A key feature of the system, according to a release from Medtronic, is its AI-enabled architecture, which supports planning and visualization before, during, and after surgery. For cranial procedures, this includes automatic tractography, which generates patient-specific brain maps and helps visualize neural pathways associated with critical functions.
“For complex brain surgeries, the more information you have, the better decisions you can make,” said Michael Ivan, MD, 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.”
The system also integrates intraoperative ultrasound using GE HealthCare’s bkActiv platform, providing additional real-time imaging during procedures.
For ENT applications, the system is designed to support navigation and visualization in anatomically complex areas such as the sinuses and skull base.
“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 Vijay Ramakrishnan, MD, professor of otolaryngology–head and neck surgery at Indiana University School of Medicine, in a release. “The Stealth AXiS system leverages innovative technologies to enhance surgeon workflows and support procedural efficiency and confidence in the operating room.”
The system is built on a software-based architecture intended to support future updates and expanded capabilities, as well as integration with other technologies within Medtronic’s broader surgical ecosystem.
Photo caption: Stealth AXiS surgical system
File photo / Medtronic
