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Home » Medtronic wins FDA clearance for Stealth AXiS robot in cranial, ENT procedures

Medtronic wins FDA clearance for Stealth AXiS robot in cranial, ENT procedures

March 27, 2026 By Sean Whooley

Medtronic Stealth AXiS surgical robot for spine procedures (1)
The Stealth AXiS surgical robotic platform for spine procedures. [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) announced today that the FDA cleared its Stealth AXiS surgical robotic system for new indications.

The Stealth AXiS system already held clearance for spine surgery, which it picked up last month. Now, its indications also cover cranial and ear, nose and throat (ENT) procedures.

Stealth AXiS brings planning, navigation and robotics together into a single, intelligent system. Michael Carter, SVP and president of Medtronic Cranial & Spinal Technologies, spoke to MassDevice recently to outline the benefits of the system.

Medtronic built its system to support a range of surgeon preferences, clinical complexity and care settings. It designed Stealth AXiS for use across hospitals and the increasingly popular ambulatory surgery centers (ASCs). The system can operate in these settings without relying on multiple standalone technologies.

Stealth AXiS combines familiar navigation workflows with a modular robotic design, the medtech giant says. It allows institutions to deploy what they need and expand over time as needs evolve. The company built the system on its existing Mazor and StealthStation technologies.

This marks the latest surgical robotics advancement for Medtronic, which also won FDA approval for its Hugo soft tissue robot at the end of 2025.

(Learn more about Medtronic and the surgical robotics space in our MassDevice Surgical Robotics Special Report. Download the report for free here.)

Medtronic said Stealth AXiS’ latest clearance reinforces the company’s strategy to deliver connected technologies that support surgeons across multiple specialties on a single platform.

The medtech giant says a major feature of Stealth AXiS comes in the form of AI-enabled architecture. It supports advanced planning and visualization before, during and after surgery. The platform integrates intraoperative ultrasound through GE HealthCare’s bkActiv platform as well.

In cranial procedures, AI-based automatic tractography helps surgeons generate patient-specific brain maps and visualize critical neural pathways associated with essential brain functions.

For ENT procedures, Stealth AXiS delivers high-precision navigation and advanced visualization tailored to the intricate anatomy of the sinuses and skull base.

Medtronic said the system’s flexible architecture supports continuous software innovation and expanded capabilities. It hopes the deeper ecosystem of connectivity helps to shape the “next era of surgery.

Commentary from Medtronic officials

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.”

Filed Under: 510(k), Artificial Intelligence (AI), Digital Health, Featured, Food & Drug Administration (FDA), Health Technology, Machine Learning (ML), Neurological, Otolaryngology/Ear, Nose & Throat (ENT), Regulatory/Compliance, Robotic-Assisted, Software / IT, Surgical, Surgical Robotics Tagged With: FDA, Medtronic

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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