Medtronic received approval under the CE Mark for the Stealth AXiS surgical system, a next-generation platform indicated for spine and cranial procedures. The CE Mark follows FDA clearances earlier this year.
Stealth AXiS integrates planning, navigation, and robotic execution into a single, modular platform. Designed to support a wide range of clinical workflows and surgical environments, the system enables hospitals to adopt capabilities based on their needs, while maintaining flexibility for future expansion.
A key innovation of the system is LiveAlign segmental tracking that allows surgeons to visualize anatomical motion and patient alignment in real time during spine procedures. As a cornerstone of Medtronic’s AiBLE ecosystem, the Stealth AXiS system connects pre-, intra-, and post-operative workflows.
“Receiving CE mark for the Stealth AXiS system marks an important milestone in expanding access to advanced surgical technologies across Europe,” said Oli Prosperi, Vice President, International Commercial, Cranial & Spinal Technologies, Medtronic. “Achieving CE mark in the current regulatory environment, under EU Medical Device Regulation, underscores our commitment to bringing meaningful innovation into a highly diverse healthcare landscape.”
Medtronic received approval under the CE Mark for the Stealth AXiS surgical system, a next-generation platform indicated for spine and cranial procedures. The CE Mark follows FDA clearances earlier this year.
Stealth AXiS integrates planning, navigation, and robotic execution into a single, modular platform. Designed to support a wide...
Medtronic received approval under the CE Mark for the Stealth AXiS surgical system, a next-generation platform indicated for spine and cranial procedures. The CE Mark follows FDA clearances earlier this year.
Stealth AXiS integrates planning, navigation, and robotic execution into a single, modular platform. Designed to support a wide range of clinical workflows and surgical environments, the system enables hospitals to adopt capabilities based on their needs, while maintaining flexibility for future expansion.
A key innovation of the system is LiveAlign segmental tracking that allows surgeons to visualize anatomical motion and patient alignment in real time during spine procedures. As a cornerstone of Medtronic’s AiBLE ecosystem, the Stealth AXiS system connects pre-, intra-, and post-operative workflows.
“Receiving CE mark for the Stealth AXiS system marks an important milestone in expanding access to advanced surgical technologies across Europe,” said Oli Prosperi, Vice President, International Commercial, Cranial & Spinal Technologies, Medtronic. “Achieving CE mark in the current regulatory environment, under EU Medical Device Regulation, underscores our commitment to bringing meaningful innovation into a highly diverse healthcare landscape.”
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