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Home Medical Devices US Medtronic’s Stealth AXiS Spine Robotics Gains FDA Approval
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Medtronic’s Stealth AXiS Spine Robotics Gains FDA Approval

16th February 2026
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Albert Baines

Medtronic has achieved a significant milestone with FDA approval for its Stealth AXiS spine surgery robotics platform. This cutting-edge system merges robotics, planning, and navigation, promising to transform spine surgical procedures across the U.S. By providing an integrated solution specific to spine surgeries, Medtronic aims to reduce reliance on multiple separate technologies, streamlining operations for hospitals and clinics.

The Stealth AXiS system stands as a crucial component of Medtronic’s AiBLE smart ecosystem, offering a unique architecture that caters to various surgeon preferences and complex clinical scenarios. This advancement is particularly important as it aligns with the increasing demand for more efficient and precise surgical interventions. Noteworthy is the system’s future expansion potential; Medtronic plans to extend its applications to cranial and ENT surgeries pending further clearances. The modular design enables facilities to scale the system as needed, offering flexibility and adaptability to evolving clinical needs. A standout feature, LiveAlign segmental tracking, enhances surgical precision by providing real-time visualization of anatomical movements and surgical adjustments, reducing the need for frequent imaging.

Medtronic’s FDA approval of the Stealth AXiS system marks a pivotal step in advancing spine surgery technology. With its innovative integration into the AiBLE ecosystem, this platform is poised to enhance surgical outcomes through streamlined workflows and consistent execution. As healthcare facilities anticipate these state-of-the-art enhancements, Medtronic continues to pave the way for personalized and predictable surgical care, setting the stage for future medical advancements.

 

 
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