GE HealthCare Receives FDA Clearance and CE Mark for Allia Moveo

GE HealthCare has received U.S. FDA 510(k) clearance and CE Marking for its Allia™ Moveo system and completed the first global installation in France.

Photo
Source: GE HealthCare

Regulatory Clearance and Market Milestone

GE HealthCare has announced that Allia™ Moveo has received 510(k) clearance from the U.S. Food and Drug Administration and CE Marking in Europe. The system was first presented at the Radiological Society of North America Annual Meeting 2025 and is now approved for clinical use across a wide range of cardiovascular, vascular, non-vascular, interventional, and surgical procedures.

According to GE HealthCare, Allia Moveo is designed to address spatial and workflow constraints in interventional suites through a compact, cable-free C-arm, an intuitive user interface, and AI-supported guidance tools. The system is intended to support efficient positioning, high-quality image acquisition, and integration with other clinical technologies.

Allia™ Moveo system shown in the picture
Source: GE HealthCare

First Global Installation in France

The first worldwide installation of Allia Moveo was completed at Hôpital Marie-Lannelongue, a French center specializing in thoracic, vascular, and cardiac surgery and a national reference for complex aortic pathologies. The platform is intended to support cone-beam computed tomography and interventional workflows in cardiology and vascular care.

The ergonomic system features a wide-bore design, flexible table panning, and maneuverability intended to accommodate a broad range of patient body sizes while supporting staff comfort and procedural access.

“My initial experience with Allia Moveo has been incredible, it’s a real game changer. With Allia Moveo, we had this opportunity to position the system very quickly in any working position that will adapt the best to us,” said Stephan Haulon, M.D., Ph.D., Vascular Surgeon, Head of Aortic Center and Vascular Surgery, Hôpital Saint-Joseph, Paris, France. “One of the major milestones of this new system is having access to the reconstruction of the cone beam CT with CleaRecon DL, which is AI driven and gives you much better image quality.”

Imaging and Guidance Capabilities

Allia Moveo integrates several advanced 3D imaging and guidance tools designed to support clinical decision-making during minimally invasive procedures, including:

  • CleaRecon DL: AI-driven reconstruction designed to reduce streak artifacts caused by arterial blood flow
  • Motion Freeze: A tool intended to compensate for involuntary respiratory motion
  • Metallic Artifact Reduction: Designed to improve visualization of anatomy near metallic implants
  • Augmented guidance solutions: Including compatibility with the ASSIST advanced clinical applications portfolio and selected third-party systems


The system is also designed to operate quietly, supporting communication among care teams during multi-user procedures.

U.S. Installation and Clinical Perspective

Following the installation in France, Baylor St. Luke’s Medical Center became the first site in the United States to deploy Allia Moveo.

“We are honored to be the first hospital in the United States to install Allia Moveo, and proud to help advance the next generation of interventional care,” said Brad Lembke, MD, President of Baylor St. Luke’s Medical Center. “This innovative platform enhances how our clinicians navigate complex minimally invasive procedures by improving mobility, image clarity, and workflow efficiency. It strengthens our ability to deliver precise, patient-centered care while supporting our teams with technology designed for the evolving demands of modern interventional medicine.”

Industry Context and Outlook

“With Allia Moveo, we’re elevating the clinician experience, removing complexity, accelerating workflow, and enabling greater control during procedures,” said Arnaud Marie, General Manager, Interventional Solutions at GE HealthCare. “We are excited to collaborate with leading experts at Hôpital Marie-Lannelongue on the first installation of this system, which is a defining step forward for care in the interventional suite, and a testament to our shared commitment to advancing meaningful innovation with the goal of supporting better outcomes for care teams and the patients they treat.”

Source: GE HealthCare

Channels

related articles
popular articles