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Medtronic earns FDA clearance for Stealth AXiS spinal surgery system

Global healthcare solutions provider, Medtronic PLC, recently announced a significant leap forward in the field of spinal surgery. The U.S. Food and Drug Administration (FDA) has given clearance to its highly advanced Stealth AXiS surgical system. This intelligent system brings together planning, navigation, and robotics into one platform, designed specifically for spinal surgery.

The Stealth AXiS system brings together planning, navigation, and robotics into one platform for spine surgery. | Source: Medtronic

The Impact of Stealth AXiS System

According to Ronald A. Lehman, Jr., M.D., tenured professor of orthopaedic surgery (neurological surgery) at Columbia University, the Stealth AXiS system represents a significant advancement in spinal surgery. With this system, surgeons can gain real-time visibility into the spine’s motion during a procedure, allowing them to more effectively execute their surgical plan without disrupting workflow. This game-changing technology addresses one of the biggest challenges in spine surgery – understanding and responding to spine movement during a procedure.

Key Features of the Stealth AXiS System

A standout feature of the Stealth AXiS system is its LiveAlign segmental tracking. This innovative capability allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spinal surgery without repeatedly needing imaging. It significantly reduces reliance on manual steps and workflow disruption, supporting more consistent execution of patient-specific surgical plans.

Stealth AXiS is a critical part of Medtronic’s MintegratesAiBLE smart ecosystem. It enables an intuitive and seamless flow of information across the surgical continuum. It integrates planning, navigation, and execution within a single platform, streamlining workflows and supporting the exchange of insights before, during, and after spine surgery. The system is designed to connect devices, software, and data in a meaningful way.

Modular Systems by Medtronic

Medtronic has designed Stealth AXiS to support a wide range of surgeon preferences, clinical complexity, and care settings. Its modular robotic design allows institutions to deploy what they need today and expand over time as clinical needs evolve. This flexible approach makes it an ideal solution for hospitals and ambulatory surgery centers.

Michael Carter, senior vice president and president of Medtronic Cranial & Spinal Technologies, acknowledges the complexity and variability of spine surgery. He asserts that the Stealth AXiS system is designed to make advanced technology more usable and clinically meaningful, helping surgeons deliver more predictable, personalized care.

Medtronic, with over 95,000 employees across more than 150 countries, is a global leader in addressing the complex challenges faced by spine and neurosurgeons. Its portfolio includes 150 products covering more than 20 pathologies, serving over 4 million patients annually. The company’s AiBLE ecosystem integrates advanced technologies, data, and AI to enhance surgical precision, improve workflow efficiency, and achieve better outcomes.

For more information about Medtronic’s Stealth AXiS surgical system, click Here.

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