GE HealthCare Secures FDA Clearance and CE Mark for Allia Moveo
GE HealthCare has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Marking for Allia Moveo, its latest interventional imaging platform, enabling broader clinical adoption across global markets. The system was first introduced at RSNA 2025 and is designed to support a wide range of cardiovascular, vascular, and interventional procedures, with a focus on mobility, workflow efficiency, and image-guided precision.
The first global installation of Allia Moveo was completed at Hôpital Marie-Lannelongue in France, a national reference center for complex thoracic, vascular, and cardiac procedures. The hospital plans to use the platform to support vascular and cardiology interventions, including applications requiring cone-beam computed tomography. Designed with a compact, cable-free C-arm and wide-bore configuration, the system aims to improve access and flexibility for care teams while accommodating patients of varying body sizes.
“My initial experience with Allia Moveo has been incredible, it’s a real game changer,” said Stephan Haulon, M.D., Ph.D., Head of the Aortic Center and Vascular Surgery at Hôpital Marie-Lannelongue. He highlighted the system’s rapid positioning and the availability of cone-beam CT reconstruction using CleaRecon DL, noting that the AI-driven technology delivers improved image quality during procedures.
Allia Moveo incorporates several advanced imaging and motion-management features intended to support complex minimally invasive workflows. These include AI-based artifact reduction to improve cone-beam CT clarity, tools to compensate for respiratory motion, and software designed to reduce metallic artifacts. The platform is also compatible with GE HealthCare and third-party systems to support integrated interventional environments.
Following the French installation, Baylor St. Luke’s Medical Center in Houston became the first site in the United States to install Allia Moveo. “We are honored to be the first hospital in the United States to install Allia Moveo,” said Brad Lembke, MD, President of Baylor St. Luke’s Medical Center, adding that the system strengthens the hospital’s ability to support complex minimally invasive procedures through improved mobility and imaging performance. GE HealthCare stated that regulatory clearance and early installations represent a key step in expanding access to the platform, though availability may vary by region.
