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

 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.

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.

https://www.massdevice.com/medtronic-fda-clearance-stealth-axis-cranial-ent/