Medtronic’s Stealth Axis surgical system has obtained US Food and Drug Administration (FDA) clearance for use in cranial and ear, nose, and throat (ENT) procedures.

Building on the system’s initial FDA clearance for use in spine procedures in February 2026, Stealth Axis is designed to unify surgical planning, navigation, and robotics into a single system to provide surgeons with greater precision and real-time insights during surgical procedures.

Comprised of a floor‑mounted robotic arm and viewing consoles, Medtronic says that Stealth Axis is underpinned by artificial intelligence (AI)-based architecture to support surgical planning and visualisation protocols before, during, and after surgery.

For cranial surgical procedures, Stealth includes AI-based automatic tractography to assist surgeons in the generation of patient-specific brain maps and to visualise critical neural pathways associated with essential brain function. The system also provides additional real-time imaging insights during surgery via an integration with GE HealthCare’s bkActiv ultrasound system.

For ENT procedures, Stealth has been built around real-world ENT workflows, availing surgeons with navigation and advanced visualisation tools that have been tailored to the intricate anatomy of the sinuses and skull base. According to Medtronic, Stealth’s provision of sharper anatomical detail and faster responsiveness provides surgeons with heightened confidence regarding decision-making in the operating room (OR).

Medtronic views Stealth Axis as the ‘cornerstone’ of AiBLE, the company’s smart ecosystem that unites protocols including full body imaging technology, data aggregation and analytics, and software portals to support pre-, intra-, and post-operative workflows for spine, cranial, and ENT surgical procedures.

Michael Carter, senior vice president and president of Medtronic cranial and spinal technologies, commented: "Cranial procedures require an exceptional level of precision, planning, and real-time insight.

"With the Stealth AXiS surgical system, we are bringing together advanced navigation, robotics, and AI-enabled capabilities within the AiBLE smart ecosystem to support surgeons with deeper insights across the surgical workflow."

According to GlobalData analysis, the global robotic surgery systems market is growing at a compound annual growth rate (CAGR) of 11.2% and is projected to reach a valuation of $10.2bn in 2025, up from $3.5bn in 2025.

Intuitive holds a commanding lead position in the space, with the company’s da Vinci line of surgical robots accounting for a market share of 57.7% in the US and 60% globally in 2025, as per a GlobalData market model. Meanwhile, Medtronic holds a market share of 2.8% in the US and globally.