Medtronic Receives FDA Clearance for Stealth AXiS Surgical System for Cranial and ENT Procedures
Published: 07 Apr 2026
Author: Towards Healthcare
Medtronic is 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. For spine procedures, 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.
Senior Vice President and President of Medtronic Cranial & Spinal Technologies, Michael Carter, said that cranial procedures require an exceptional level of precision, planning, and real-time insight.
According to Towards Healthcare, the AI in spine surgery market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 2.25 billion in 2026 to approximately USD 13.29 billion by 2035, representing a compound annual growth rate (CAGR) of 21.8% from 2026 to 2035. Growth is driven by advanced surgical techniques and AI-based automatic tractography, which generates patient-specific brain maps to support surgeons with deep or more insight throughout the surgical workflow, thereby improving efficiency and yielding better outcomes for patients.
AI-enabled architecture
Cranial procedures include an AI-based automatic tractography system that helps surgeons generate patient-specific brain maps and visualise critical neural pathways associated with essential brain functions. The platform integrates with intraoperative ultrasound through GE HealthCare's bkActiv real-time imaging result.
Professor of Otolaryngology-Head & Neck Surgery at Indiana University School of Medicine, Dr. Vijay Ramakrishnan said, 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.
About Medtronic
It is a global healthcare technology that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. The main aim is to alleviate pain, restore health, and extend life, which unite global team of passionate people across more than 150 countries.
It is powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it. We deliver innovative technologies that transform the lives of two people every second, every hour, every day.
A recent report by Towards Healthcare highlights that AI in the spine surgery market witnesses the integration of AI and advanced technology, which is transforming spine surgery by improving diagnostic precision, surgical navigation, and personalising outcomes. It also advances 3D models in machine learning enable efficient, patient-specific anatomical reconstruction while reducing manual time from hours to seconds.