Medtronic (NYSE: MDT) received U.S. Food and Drug Administration clearance for its Stealth AXiS surgical system for cranial and ear, nose, and throat procedures, the company announced from Galway, Ireland.

The system, which received FDA clearance for spine procedures in February, combines surgical planning, navigation, and robotics into a single platform. The technology includes AI-based automatic tractography for generating patient-specific brain maps and visualizing neural pathways during cranial procedures.

For ENT procedures, the system provides navigation and visualization capabilities designed for sinus and skull base anatomy. The platform integrates intraoperative ultrasound through GE HealthCare's bkActiv technology for real-time imaging during surgery.

"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.

The system operates within Medtronic's AiBLE smart ecosystem and features AI-enabled architecture designed to support surgical workflow before, during, and after procedures. The platform's architecture is designed for continuous software updates and expanded capabilities.

Dr. Michael Ivan, neurosurgeon at the University of Miami Health System, noted that "Pre-operative planning with tools like tractography may help surgeons enhance surgical efficiency and support better patient outcomes."

Medtronic's Cranial and Spinal Technologies business serves over 4 million patients annually with a portfolio of 150 products covering more than 20 pathologies. The company's ENT business impacts nearly 3 million patients each year and has been providing ENT navigation technology since introducing the LandmarX image-guided surgery system in 1998.