FDA Grants 510(k) Clearance to GE HealthCare’s Allia Moveo

GE HealthCare has earned U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Marking for Allia Moveo, a product designed to bring next-level mobility and precision to the interventional suite.

The latest Allia platform, first unveiled at the Radiological Society of North America’s (RSNA) 2025 Annual Meeting, assists clinicians in various cardiovascular, vascular, non-vascular, interventional, and surgical procedures. Allia Moveo delivers enhanced workflow through a compact, cable-free C-arm system with an intuitive user interface, and artificial intelligence (AI)-powered guidance tools to help clinicians work efficiently and adapt to the spatial constraints of traditional interventional suites.

The Hôpital Marie-Lannelongue in France—a center of excellence in thoracic, vascular and heart surgery, and national reference for complex aortic pathologies—was the world’s first medical center to complete an Allia Moveo installation. The platform is intended to enable flexible cone-beam computed tomography and support the hospital in treating vascular and cardiology diseases. The ergonomic, maneuverable system is tailored to accommodate more patients regardless of body size or weight, with a wide-bore design and effortless table panning to help care teams maintain comfort and access throughout procedures.

“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 Marie-Lannelongue (Le Plessis-Robinson), part of the Fondation Hôpital Saint-Joseph, Paris, France.* “One of the major milestones of this new system is having access to reconstruction of the cone beam CT with CleaRecon DL, which is AI-driven and gives you much better image quality.”

As interventional procedures grow more demanding, clinicians need imaging solutions that deliver clear insights and optimize workflows. During minimally invasive interventions involving multiple users, the ability to increase procedural confidence can depend on advanced imaging systems that can be positioned easily and quickly, capture high quality images and integrate with other technology – all while operating at a volume quieter than a normal conversation. Allia Moveo was created with clinicians to address these challenges by delivering an easy-to-use, high-performance system, built to enhance fluidity when space is at a premium, according to GE HealthCare.

“With Allia Moveo, we’re elevating the clinician experience, removing complexity, accelerating workflow, and enabling greater control during procedures,” stated Arnaud Marie, general manager, Interventional Solutions, at GE HealthCare. “We are excited to collaborate with 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.”

Allia Moveo is equipped with advanced 3D imaging solutions that help clinicians visualize anatomy with confidence and make informed decisions, including:

• CleaRecon DL,ⁱ AI-driven technology that removes streak artifacts caused by the pulsatile nature of blood flow in the arteries, delivering clearer, reliable images.
• Motion Freeze, a tool that helps offset involuntary respiratory motion artifact to improve image clarity.
• Metallic Artifact Reduction, designed to reveal anatomic details obscured by metal artifacts.
• Augmented guidance solutions including ASSIST advanced clinical applications portfolio—offering augmented guidance for complex procedures—along with compatibility with other GE HealthCare and third-party systems.

After its installation at Hôpital Marie-Lannelongue, Allia Moveo made its U.S. premiere at Houston’s Baylor St. Luke’s Medical Center, a member of CommonSpirit.

“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, M.D., president of Baylor St. Luke’s Medical Center.** “This 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.”

GE HealthCare is a global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services, and data analytics. The company strives to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Its Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. GE HealthCare is a $19.7 billion business with approximately 53,000 colleagues.

*Dr. Haulon is a paid consultant for GE HealthCare.

** Dr. Lembke’s statements are based on his own opinions and results that were achieved in his hospital.

Reference
ⁱ CleaRecon DL, designed to be used with Allia systems, is an option in 3DXR designed to be used with Allia systems and requires AW workstation with Volume Viewer. May not be available in all countries.