Medtronic has received the CE mark for the Stealth AXiS surgical platform that combines planning, navigation, and robotics into a single integrated system.
Approved for spine and cranial procedures, the Stealth AXiS surgical system demonstrates the platform’s ability to support a range of Medtronic’s surgical specialities.
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With flexibility for varied clinical workflows and hospital settings, the system supports customisable adoption based on each hospital’s needs while remaining open to future expansion.
A key feature of the platform is LiveAlign segmental tracking. This function allows surgeons to monitor anatomical motion and patient alignment in real time during spine procedures.
As part of Medtronic’s AiBLE ecosystem, Stealth AXiS links pre-, intra-, and post-operative workflows, supporting an integrated approach to surgery.
The system relies on an AI-driven architecture, providing advanced planning and visualisation at all stages of surgery.
In cranial surgeries, the AI-powered automatic tractography provides surgeons with patient-specific brain maps and better visibility of critical neural pathways associated with vital brain functions.
The CE mark follows the US Food and Drug Administration (FDA) clearances earlier this year, illustrating Medtronic’s capacity to deliver advanced surgical solutions to global markets.
Medtronic commercial, cranial and spinal technologies international vice-president Oli Prosperi said: “Receiving the CE mark for the Stealth AXiS system marks an important milestone in expanding access to advanced surgical technologies across Europe.
“Achieving CE mark in the current regulatory environment, under EU Medical Device Regulation (MDR), underscores our commitment to bringing meaningful innovation into a highly diverse healthcare landscape.”
Earlier this month, Medtronic completed the $585m acquisition of CathWorks, a company specialising in advancing the diagnosis and treatment of coronary artery disease, with further undisclosed earn-out payments possible after the deal.
