Medtronic Stealth AXiS: FDA-Cleared Integrated Planning, Navigation, and Robotics

Medtronic’s announcement reports U.S. FDA clearance for the Stealth AXiS surgical system for spine procedures, describing it as a next-generation platform that combines planning, navigation, and robotics in a single system.

In the company’s framing, it is designed for use across hospitals and ambulatory surgery centers without relying on multiple standalone technologies. The release focuses on how the platform is positioned and what it is designed to enable, rather than reporting clinical outcomes or comparative performance.

The press release describes Stealth AXiS as a modular platform intended to accommodate surgeon preferences, case complexity, and care settings. It states the system is designed for use across hospitals and ambulatory surgery centers and highlights a deployment concept in which institutions can “deploy what they need today and expand over time” as needs evolve. Alongside the spine indication, Medtronic notes that the system’s underlying architecture is designed to support future cranial and ENT applications, pending additional 510(k) clearance. Overall, the release presents the system as a configurable OR technology stack within a single platform construct.

A central feature highlighted in the announcement is LiveAlign segmental tracking, which Medtronic calls an “industry-first” capability. The company describes LiveAlign as providing real-time visualization of anatomic motion, surgical adjustments, and patient alignment during spine surgery, and says this can be done without repeated imaging. The release links this to workflow—reducing reliance on manual steps and minimizing disruption during a case—while framing the feature as supporting more consistent execution of patient-specific surgical plans. In Medtronic’s description, LiveAlign is intended to keep alignment and motion information visible as intraoperative conditions change.

Medtronic positions Stealth AXiS as a cornerstone of its AiBLE smart ecosystem, using “native integration” to describe how planning, navigation, and execution are combined within the platform. The company says this configuration is intended to support a more seamless flow of information across the “surgical continuum,” including exchange of insights before, during, and after spine surgery, and describes the broader ecosystem as connecting devices, software, and data. In the release, these points are presented at the level of platform connectivity and workflow continuity rather than as a statement about specific third-party implant planning software compatibility or named patient-specific implant programs. The overall message emphasizes built-in integration oriented around cross-phase information flow.

On rollout and usability, the release frames the system as building on familiar navigation workflows and pairing them with a modular robotic design to create a “pathway for adoption,” without detailing credentialing requirements, proctoring structures, or formal training curricula.

Key Takeaways:

• The company announcement reports FDA clearance in the U.S. for an integrated planning, navigation, and robotics platform for spine procedures.
• LiveAlign is described as real-time segmental tracking intended to visualize motion and alignment during surgery without repeated imaging, in the vendor’s framing.
• Stealth AXiS is positioned within the AiBLE ecosystem with native integration and modular deployment across hospitals and ASCs, alongside vendor-described usability and rollout concepts.