Wednesday, February 18, 2026

Medtronic earns FDA clearance for Stealth AXiS spinal surgical procedure system


The Stealth AXiS system brings collectively planning, navigation, and robotics into one platform for backbone surgical procedure. | Supply: Medtronic

Medtronic PLC final week introduced the U.S. Meals and Drug Administration has cleared its Stealth AXiS surgical system, an clever system for spinal surgical procedure.

The Stealth AXiS system is cleared for backbone procedures within the U.S. It has an underlying structure designed to help future cranial and ear, nostril, and throat (ENT) purposes, pending 510(okay) clearance.

“The Stealth AXiS system represents a significant step ahead in how we take into consideration navigation and robotics working collectively,” stated Ronald A. Lehman, Jr., M.D., tenured professor of orthopaedic surgical procedure (neurological surgical procedure) at Columbia College. He’s additionally chief of the Backbone Surgical procedure Division and backbone medical director at The Backbone Hospital at NewYork-Presbyterian/The Allen Hospital, in addition to a paid marketing consultant to Medtronic.

“One of many greatest challenges in backbone surgical procedure has been understanding and responding to how the backbone strikes throughout a process,” Lehman stated. “The Stealth AXiS system provides surgeons real-time visibility into that movement, serving to us extra persistently obtain our surgical plan with out interrupting workflow. To me, that is really game-changing expertise.”

Stealth AXiS consists of LiveAlign segmental monitoring

A key side of the Stealth AXiS system is LiveAlign segmental monitoring, which permits surgeons to visualise anatomic movement, surgical changes, and affected person alignment in actual time throughout backbone surgical procedure, with out the necessity for repeated imaging. This functionality helps scale back reliance on handbook steps and workflow disruption, supporting extra constant execution of patient-specific surgical plans, stated Medtronic.

The firm described Stealth AXiS as a cornerstone of its MintegratesAiBLE sensible ecosystem. It claimed that the system allows a extra intuitive and seamless move of data throughout the surgical continuum.

Stealth AXiS natively integrates planning, navigation, and execution inside a single platform. This allows it to assist streamline workflows and help the trade of insights earlier than, throughout, and after backbone surgical procedure, in keeping with Medtronic. The system permits the broader AiBLE ecosystem to attach gadgets, software program, and knowledge in a extra significant means, the corporate stated.



Medtronic designs modular techniques

Medtronic stated it constructed Stealth AXiS to help a variety of surgeon preferences, medical complexity, and care settings. The corporate asserted that its platform can be utilized throughout hospitals and ambulatory surgical procedure facilities with out counting on a number of standalone applied sciences.

Stealth AXiS combines acquainted navigation workflows with a modular robotic design, famous Medtronic. This enables establishments to deploy what they want right now and develop over time as medical wants evolve, it stated.

“Backbone surgical procedure is complicated, and variability stays an actual problem,” stated Michael Carter, senior vp and president of Medtronic Cranial & Spinal Applied sciences. “The Stealth AXiS system is designed to make superior expertise extra usable and clinically significant, serving to surgeons ship extra predictable, customized care whereas laying the inspiration for continued innovation.”

Galway, Eire-based Medtronic has greater than 95,000 staff throughout over 150 international locations. The rising firm stated its applied sciences and therapies deal with 70 well being situations and embrace cardiac gadgets, surgical robotics, insulin pumps, surgical instruments, and affected person monitoring techniques. Medtronic has positioned its Hugo system as an alternative choice to the bigger Intuitive Surgical da Vinci surgical robotic.

Medtronic Cranial and Spinal Applied sciences stated it’s a international market chief addressing the complicated challenges confronted by backbone and neurosurgeons. Its portfolio consists of 150 merchandise protecting greater than 20 pathologies, and it serves over 4 million sufferers yearly.

Constructing on a legacy of innovation, Medtronic stated its AiBLE ecosystem integrates superior applied sciences, knowledge, and AI with a patient-centric strategy. The firm provides customizable techniques to boost surgical precision, enhance workflow effectivity, and obtain higher outcomes.

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