The Stealth AXiS™ surgical system is a next-generation platform that integrates surgical planning, navigation, and robotic assistance into a single, unified system for spinal procedures.
Developed by Medtronic, the system accommodates diverse surgeon preferences, varying clinical complexity, and different care environments. It is intended for use in both hospitals and ambulatory surgery centres without the need for multiple separate technologies.
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The system received clearance from the US Food and Drug Administration (FDA) in February 2026 for spinal surgery in the US. It also received additional 510(k) clearance for cranial and ear, nose and throat (ENT) procedures in the following month.
Medtronic received the CE mark for the system in Europe in April 2026, while the CE mark for ENT procedures was granted in June of the same year.
Stealth AXiS system design and components
The Stealth AXiS system is built on the StealthStation™ platform and embedded within the AiBLE™ ecosystem.
It consists of three primary elements: the core, the autopilot unit, and the planning station.
The core component incorporates an extended camera handle with 360° rotation to enhance manoeuvrability during surgery. It includes 4K monitors and increased computing capacity to support high‑resolution visualisation and advanced processing. The core is configured for both optical and electromagnetic (EM) navigation in spine, cranial, and ENT applications.
The Stealth AXiS autopilot module includes a 360° active tracking device to support real‑time trajectory alignment. It incorporates a force sensor designed to provide feedback when excessive force is applied, a sterile tool changer to facilitate transitions between procedural steps, and surgeon controls that allow sterile users to perform key tasks. The unit also features a floor‑mounted robotic arm to provide structural rigidity and stability.
The Stealth AXiS planning station supports planning either remotely or on site, with direct connectivity to the Stealth AXiS system and browser‑based access that reflects the navigation system interface. It offers a multi-user, hospital‑based server option to enable secure, collaborative planning. The planning workflow includes integrated digital imaging and communications in medicine (DICOM) transfer, and an HTML‑based secure connection.
Technology details of the Stealth AXiS
The platform’s key technology is the LiveAlign™ segmental tracking feature, described as an industry-first capability. This function enables surgeons to monitor anatomical motion, intraoperative adjustments, and overall patient alignment in real time during spinal procedures, without repeated imaging.
The technology is intended to lessen dependence on manual steps and minimise workflow interruptions, thereby supporting more consistent implementation of patient-specific surgical plans.
The platform’s AI‑based surgical planning is intended to accelerate pre‑operative decision‑making. In spinal surgery, it is used to simplify construct design and support alignment planning, while in cranial surgery, it is applied to automated probabilistic constrained spherical deconvolution (CSD) tractography, which provides rapid generation of patient‑specific fibre maps without manual input.
The platform incorporates tools to automate screw trajectory planning and alignment, as well as planning for interbody devices, facet joints, and rods.
Key planning features include auto‑segmentation and anatomical labelling, 3D measurements, and access to more than 30 alignment metrics.
Details of the AiBLE ecosystem
The Stealth AXiS surgical system is configured to be used across both routine and complex spinal procedures and to interface seamlessly with Medtronic’s AiBLE smart ecosystem.
As a central component of the AiBLE ecosystem, the Stealth AXiS system is designed to facilitate an intuitive and continuous flow of information across the surgical pathway.
By incorporating planning, navigation, and execution within a single platform, it aims to streamline workflow and support the exchange of insights before, during, and after spine surgery.
Within the broader AiBLE framework, this platform is positioned to help link devices, software, and data, including integration from CT to O-arm™ imaging. This integration supports intraoperative navigation, high-resolution 3D visualisation, and a unified registration process, which can be used to compare planned versus actual implant placement postoperatively.
The O-arm imaging system also interfaces with the UNiD™ adaptive spine intelligence (ASI) system to support aligned construct execution and workflow standardisation.
In addition, the Stealth-Midas™ high-speed drill system enables navigated drilling and facet decortication within the same integrated environment.
Benefits of the Stealth AXiS system
The Stealth AXiS system is designed with a flexible architecture and maintains compatibility with existing instrumentation while supporting a structured pathway for technology updates.
It is designed to scale over time, enabling surgeons and healthcare providers to expand functionality in line with changing clinical requirements.
Additionally, the system is structured as a connected, modular surgical platform that can adapt to evolving workflows and emerging technologies, including AI-enabled capabilities.
