Medtronic PLC last week announced the U.S. Food and Drug Administration has cleared its Stealth AXiS surgical system, an intelligent system for spinal surgery.

The Stealth AXiS system is cleared for spine procedures in the U.S. It has an underlying architecture designed to support future cranial and ear, nose, and throat (ENT) applications, pending 510(k) clearance.

“The Stealth AXiS system represents a meaningful step forward in how we think about navigation and robotics working together,” said Ronald A. Lehman, Jr., M.D., tenured professor of orthopaedic surgery (neurological surgery) at Columbia University. He is also chief of the Spine Surgery Division and spine medical director at The Spine Hospital at NewYork-Presbyterian/The Allen Hospital, as well as a paid consultant to Medtronic.

“One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure,” Lehman said. “The Stealth AXiS system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow. To me, this is truly game-changing technology.”

Stealth AXiS includes LiveAlign segmental tracking

A key aspect of the Stealth AXiS system is LiveAlign segmental tracking, which allows surgeons to visualize anatomic motion, surgical adjustments, and patient alignment in real time during spine surgery, without the need for repeated imaging. This capability helps reduce reliance on manual steps and workflow disruption, supporting more consistent execution of patient-specific surgical plans, said Medtronic.

The company described Stealth AXiS as a cornerstone of its MintegratesAiBLE smart ecosystem. It claimed that the system enables a more intuitive and seamless flow of information across the surgical continuum.

Stealth AXiS natively integrates planning, navigation, and execution within a single platform. This enables it to help streamline workflows and support the exchange of insights before, during, and after spine surgery, according to Medtronic. The system allows the broader AiBLE ecosystem to connect devices, software, and data in a more meaningful way, the company said.

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Medtronic designs modular systems

Medtronic said it built Stealth AXiS to support a wide range of surgeon preferences, clinical complexity, and care settings. The company asserted that its platform can be used across hospitals and ambulatory surgery centers without relying on multiple standalone technologies.

Stealth AXiS combines familiar navigation workflows with a modular robotic design, noted Medtronic. This allows institutions to deploy what they need today and expand over time as clinical needs evolve, it said.

“Spine surgery is complex, and variability remains a real challenge,” said Michael Carter, senior vice president and president of Medtronic Cranial & Spinal Technologies. “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.”

Galway, Ireland-based Medtronic has more than 95,000 employees across over 150 countries. The growing company said its technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, and patient monitoring systems. Medtronic has positioned its Hugo system as an alternative to the larger Intuitive Surgical da Vinci surgical robot.

Medtronic Cranial and Spinal Technologies said it is a global market leader addressing the complex challenges faced by spine and neurosurgeons. Its portfolio includes 150 products covering more than 20 pathologies, and it serves over 4 million patients annually.

Building on a legacy of innovation, Medtronic said its AiBLE ecosystem integrates advanced technologies, data, and AI with a patient-centric approach. The company offers customizable systems to enhance surgical precision, improve workflow efficiency, and achieve better outcomes.

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