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Robotics

Medtronic Receives FDA Clearance for Stealth AXiS Spine Surgery System

Highlights

  • Medtronic’s Stealth AXiS system gains FDA clearance for U.S. spine surgeries.

  • The platform integrates real-time tracking, navigation, and modular robotics.

  • Clinicians gain potential for improved workflow and customizable surgical planning.

Kaan Demirel
Last updated: 18 February, 2026 - 3:20 am 3:20 am
Kaan Demirel 2 hours ago
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Spine surgeons in the United States will soon have access to Medtronic’s newest surgical platform, the Stealth AXiS system, following the company’s recent FDA clearance. Designed to assist clinicians with real-time imaging and workflow integration, the Stealth AXiS aims to streamline spine procedures while addressing key challenges such as anatomical movement and surgical plan consistency. By combining navigation and robotics into a single platform, Medtronic’s development could ultimately influence how minimally invasive spine surgery is performed across diverse care settings, including both hospitals and ambulatory surgery centers.

Contents
How Does LiveAlign Segmental Tracking Work?What Role Does the AiBLE Ecosystem Play?How Might Stealth AXiS Impact Surgical Practice?

Stealth AXiS emerges as a successor to Medtronic’s ongoing surgical innovations, building on past advancements in robot-assisted and AI-integrated systems. Previous FDA clearances for products like the Hugo surgical robot focused primarily on multi-specialty applications but had limited native integration features. With Stealth AXiS, the company leverages segmental tracking, which represents a more specialized evolution in patient alignment monitoring and workflow continuity during spine procedures, setting it apart from earlier, more fragmented solutions on the market.

How Does LiveAlign Segmental Tracking Work?

LiveAlign segmental tracking enables continuous visualization of spinal movements during surgery, reducing reliance on repeated intraoperative imaging. The company describes this capability as essential for executing patient-specific surgical plans more reliably, as surgical teams receive instant feedback on spinal alignment. According to Medtronic, integrating navigation, planning, and robotics in real time supports an uninterrupted surgical workflow.

What Role Does the AiBLE Ecosystem Play?

Stealth AXiS is positioned within Medtronic’s broader AiBLE smart ecosystem, a framework intended to facilitate seamless information flow across surgical tasks. Through native integration, the system connects devices, data, and software—aiming to improve communication across surgical stages and adaptability for future procedural expansions, such as cranial and ENT surgeries. A Medtronic spokesperson noted,

“The Stealth AXiS system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalized care while laying the foundation for continued innovation.”

How Might Stealth AXiS Impact Surgical Practice?

Surgeons face unpredictable variables in spinal alignment and movement, and Stealth AXiS’s modular platform intends to address this by providing operational flexibility. Institutions can select specific features, scaling the system as needs evolve, without investing in multiple standalone technologies. The system maintains compatibility with various care environments, aiming for consistency across clinical practices. As described by Ronald A. Lehman, Jr., M.D.,

“The Stealth AXiS system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow.”

Medtronic continues to expand its robotics portfolio, competing with industry leaders like Intuitive Surgical and building out customizable, patient-centered platforms that integrate robotics, surgical navigation, and data analytics. With FDA clearance for Stealth AXiS, the company extends its reach in the highly competitive spine and neurosurgery market. The AiBLE system framework may also serve as a launching pad for additional advanced technologies as Medtronic awaits further regulatory clearances for expanded procedural indications.

As more hospitals and surgery centers adopt integrated surgical robotics, clinicians are likely to expect unified systems that provide not only accuracy but also efficiency and adaptability. Real-time tracking and modularity give healthcare providers more control over outcomes while remaining adaptable to advances in navigation and surgical planning technology. For medical institutions evaluating new investments, scalability, compatibility, and outcome data will remain key considerations. Readers interested in surgical technology may find it useful to watch for further clinical validation and updates on expanded uses of the Stealth AXiS system.

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Kaan Demirel
By Kaan Demirel
Kaan Demirel is a 28-year-old gaming enthusiast residing in Ankara. After graduating from the Statistics department of METU, he completed his master's degree in computer science. Kaan has a particular interest in strategy and simulation games and spends his free time playing competitive games and continuously learning new things about technology and game development. He is also interested in electric vehicles and cyber security. He works as a content editor at NewsLinker, where he leverages his passion for technology and gaming.
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