Medtronic has announced the successful completion of its first clinical cases using the Stealth AXiS surgical system, with the company noting in a press release these early cases mark a “key milestone” for neurosurgical care as the system moves from clearance into real-world clinical use.
Medtronic also announced earlier this month that Stealth AXiS had gained a European CE mark for spine and cranial procedures following two recent US Food and Drug Administration (FDA) clearances covering spine surgery, and cranial and ear, nose and throat (ENT) procedures.
“What excites me most about this platform is its ability to unify preoperative planning with real-time intraoperative intelligence,” said Joseph Osorio (University of California [UC] San Diego Health, San Diego, USA). “The integration of AI [artificial intelligence]-driven tools, combined with dynamic motion detection through LiveAlign, marks a significant step forward in how we approach precision and adaptability in spine surgery.”
The Stealth AXiS system integrates AI-driven surgical planning, advanced navigation and robotic guidance into a single platform, supporting procedures where precision, anatomical context, and workflow efficiency, are “critical”, Medtronic claims. As part of the company’s AiBLE smart ecosystem, Stealth AXiS enables a more continuous flow of information before, during and beyond surgery, helping to translate preoperative planning into “confident intraoperative execution”.
“In spine surgery, having real-time visibility into alignment and motion changes how you execute,” commented Jeffrey Gum (Norton Healthcare, Louisville, USA). “With this system, I can stay aligned to my plan without disrupting workflow. That level of intraoperative insight is something we have been looking for.”
According to Medtronic, early experiences with Stealth AXiS also underscore the value of integrating multiple layers of anatomical and procedural data into a unified workflow, particularly in cases requiring precise navigation around critical structures.
“These first clinical cases demonstrate how a connected platform can support surgeons with greater insight and predictability in the operating room,” stated Michael Carter, senior vice president and president of Medtronic Cranial and Spinal Technologies. “The Stealth AXiS system reflects how we are scaling innovation through smart ecosystems, supporting procedures that demand both broad anatomical understanding and highly targeted precision, and building a strong foundation for continued advancement across neurosurgery.”
Medtronic is set to showcase the Stealth AXiS surgical system at the upcoming American Association of Neurological Surgeons (AANS) annual scientific meeting (1–4 May 2026, San Antonio, USA).
