Medtronic Secures FDA Clearance for Stealth AXiS Robot in Cranial and ENT Procedures

Medtronic has received U.S. FDA clearance for expanded indications of its Stealth AXiS surgical robotic system, extending its use to cranial and ear, nose, and throat (ENT) procedures. The system had previously received clearance for spine surgery.

Stealth AXiS integrates surgical planning, navigation, and robotics into a unified platform, designed to support a wide range of surgical preferences, clinical complexities, and care environments. It can be deployed across hospitals as well as ambulatory surgery centers (ASCs), without requiring multiple standalone systems.

The platform combines established navigation workflows with a modular robotic architecture, enabling healthcare providers to scale capabilities based on evolving needs. It is built on Medtronic’s existing Mazor and StealthStation technologies.

The latest clearance reflects Medtronic’s continued push in surgical robotics, following FDA approval of its Hugo soft tissue robotic system in late 2025.

A key feature of Stealth AXiS is its AI-enabled architecture, which supports advanced planning and visualization throughout the surgical process. The system also integrates intraoperative ultrasound through GE HealthCare’s bkActiv platform.

In cranial procedures, the system uses AI-driven automatic tractography to generate patient-specific brain maps and visualise critical neural pathways. For ENT procedures, it offers high-precision navigation and enhanced visualisation tailored to complex sinus and skull base anatomy.

Medtronic noted that the platform’s flexible design supports continuous software upgrades and expanded capabilities, forming part of a connected ecosystem aimed at advancing the future of surgery.

Michael Carter, SVP and president of Medtronic Cranial & Spinal Technologies, said:
“Cranial procedures require an exceptional level of precision, planning, and real-time insight. 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.”

Sean Haag, president of Medtronic Ear, Nose & Throat, said:
“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.”