Medtronic, a global leader in healthcare technology, has received clearance from the US Food and Drug Administration (FDA) for its Stealth AXiS surgical system for use in cranial and ear, nose, and throat (ENT) procedures. Previously cleared for spine surgeries in February, the system brings together surgical planning, navigation, and robotics into one integrated platform, enabling greater precision and real-time insights during complex procedures. This milestone reinforces Medtronic’s vision of delivering connected, multi-specialty surgical technologies through a unified system.

“Cranial procedures demand the highest levels of accuracy, planning, and real-time decision-making,” said Michael Carter, senior vice president and president of Medtronic Cranial & Spinal Technologies. “The Stealth AXiS system combines advanced navigation, robotics, and AI-enabled capabilities within the AiBLE ecosystem to empower surgeons with deeper insights throughout the surgical journey.”

A key feature of the platform is its AI-enabled architecture, designed to support enhanced planning and visualization before, during, and after surgery. For cranial procedures, it includes AI-driven automatic tractography, enabling surgeons to create patient-specific brain maps and visualize critical neural pathways. The system also integrates intraoperative ultrasound through GE HealthCare’s bkActiv, providing real-time imaging support during surgery.

“For complex brain surgeries, having access to more data enables better clinical decisions,” said Dr. Michael Ivan, neurosurgeon at the University of Miami Health System. “Pre-operative tools like tractography can help improve surgical efficiency and potentially enhance patient outcomes.”

In ENT procedures, the Stealth AXiS system offers high-precision navigation and advanced visualization tailored to the intricate anatomy of the sinuses and skull base. Built around real-world surgical workflows, it delivers sharper anatomical detail, faster responsiveness, and an intuitive, surgeon-friendly experience to support confident decision-making in the operating room.

“In minimally invasive sinus and skull base surgeries, intraoperative navigation is essential for accurately identifying complex anatomical structures,” said Dr. Vijay Ramakrishnan, professor of otolaryngology at Indiana University School of Medicine. “The Stealth AXiS system leverages innovative technologies to improve workflow efficiency and enhance surgical confidence.”

The system’s flexible design also allows for continuous software upgrades, expanded capabilities, and deeper ecosystem integration, positioning it as a future-ready platform for surgical innovation.

“The Stealth AXiS system represents the next evolution in ENT navigation,” said Sean Haag, president of Medtronic’s ENT business. “Building on 25 years of leadership, it is designed to provide surgeons with greater clarity, confidence, and control, while enabling the next generation of ENT advancements.”

Medtronic Cranial and Spinal Technologies continues to redefine standards in spine and cranial care, supporting over 4 million patients annually with a portfolio of more than 150 products across 20+ pathologies. Its AiBLE ecosystem integrates advanced technologies, AI, and data-driven insights to improve precision, workflow efficiency, and patient outcomes.

Medtronic’s ENT division, a global leader in the field, impacts nearly 3 million patients each year through innovative solutions. Headquartered in Galway, Ireland, Medtronic plc remains committed to addressing some of the world’s most complex health challenges through cutting-edge healthcare technology.