Medtronic has received U.S. Food and Drug Administration (FDA) clearance of its Stealth AXiS surgical system for cranial and ear, nose, and throat (ENT) procedures.

Stealth AXiS earned FDA clearance for spine procedures last month. The surgical system unites surgical planning, navigation, and robotics into one intelligent system to support surgeons with more precision and real-time insights during complex procedures, the company said.

The platform’s AI architecture supports advanced planning and visualization before, during, and after surgery. For cranial procedures, the system boasts AI-based automatic tractography to help generate patient-specific brain maps and visualize critical neural pathway associated with essential brain functions.

“Cranial procedures require an exceptional level of precision, planning, and real-time insight,” said Michael Carter, senior VP 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.”

The platform also integrates intraoperative ultrasound via GE HealthCare’s bkActiv for further real-time imaging during procedures.

Stealth AXiS offers high-precision navigation and advanced visualization tailored to the anatomy of the sinuses and skull base. Medtronic said the system provides sharper anatomical detail and faster responsiveness to support decision-making in the OR, as well as surgeon-centered workflows to create a familiar user experience.

The system’s flexible architecture was engineered to support continuous software innovation, expanded capabilities, and deeper ecosystem connectivity.

“The Stealth AXiS surgical system represents the next era of navigation for ENT surgery,” said Sean Haag, president of the Ear, Nose, & Throat business at Medtronic. “Building on 25 years of navigation leadership, this system is designed to help surgeons move with greater clarity, confidence, and control in the OR, while creating a powerful platform for the next generation of ENT innovation.”

Earlier this week, the company entered a distribution agreement with Merit Medical Systems to offer the FDA-cleared ViaVerte, a minimally invasive and implant-free basivertebral nerve ablation (BVNA) system.