FDA clearance for spinal robotics platform

Medtronic has received FDA clearance for the Stealth AXiS robotic platform for spinal surgery.

The system is an integrated solution that combines robotics, planning, and navigation into a single platform tailored for spine procedures.

It is designed to accommodate a wide range of surgeon preferences and clinical complexities.

Medtronic’s goal is to enable hospitals and ambulatory surgery centres to perform these procedures without the need for multiple technologies.

It developed the platform to meet current requirements and enable future expansion into cranial and ear, nose, and throat applications, pending further clearances.

The modular design allows institutions to deploy only what they need at any given time, with the option to scale capabilities as clinical needs evolve.

A key feature of the system is LiveAlign segmental tracking, which provides real-time visualisation of anatomical movement, surgical adjustments, and patient alignment throughout spine surgery.

This reduces the need for repeated imaging and minimises reliance on manual workflow steps, supporting consistent execution of patient-specific surgical plans.

The Stealth AXiS system is a central part of Medtronic’s AiBLE smart ecosystem, integrating planning, navigation and execution into a single workflow.

The approach streamlines surgical processes and facilitates seamless information sharing before, during, and after surgery.

The native connectivity within the AiBLE ecosystem links devices, software, and data, enabling ‘more meaningful insight exchange across the surgical continuum’.

Medtronic senior vice-president and cranial and spinal technologies president Michael Carter said: ‘Spine surgery is complex, and variability remains a real challenge. The Stealth AXiS system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalised care while laying the foundation for continued innovation.’

Published: 08.05.2026
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