GE HealthCare announces U.S. FDA 510(k) clearance and CE Mark for Allia Moveo and marks first global installation, advancing precision care in the interventional suite

Key Terms

510(k) clearance regulatory

A 510(k) clearance is a U.S. regulatory approval that lets a medical device be sold because it is shown to be substantially similar to an already-legal device; think of it as a passport saying the new product is close enough to a known item to enter the market without a full, lengthy review. For investors, 510(k) clearance signals faster, lower-cost market access and reduced regulatory risk compared with new, untested device pathways, which can materially affect timelines, costs and revenue prospects.

ce marking regulatory

CE marking is a symbol placed on certain products showing they meet European Union safety, health and environmental rules required to sell them in the EU/EEA. For investors, it signals that a product has cleared a common regulatory hurdle—like a passport for market access—reducing legal and market-entry risk and often widening sales opportunities across European markets.

cone-beam computed tomography medical

A cone-beam computed tomography (CBCT) scan is a medical imaging method that uses a cone-shaped X-ray beam and a rotating detector to produce detailed three-dimensional pictures of the teeth, jaw, sinuses and nearby bone. Think of it as upgrading from a flat photograph to a 3D model that reveals depth and hidden structures. Investors care because CBCT adoption and equipment sales affect revenue for medical device makers, dental and imaging clinics’ capital needs, and reimbursement or regulatory changes that can change procedure volumes and profitability.

c-arm system medical

A C-arm system is a movable medical X-ray machine shaped like the letter “C” that gives surgeons and doctors real‑time images of a patient’s bones, tissues and instruments during procedures. For investors it signals exposure to hospital capital spending, device replacement cycles, regulatory approvals and reimbursement trends, because sales and upgrades of these machines track demand for image‑guided surgeries much like sales of tractors track farm activity.

3d imaging medical

Three-dimensional imaging is a set of medical technologies that create a lifelike, volumetric view of organs or structures inside the body instead of a flat picture, like turning a paper map into a small model you can rotate. Investors care because these systems often command higher prices, open new markets for devices and software, and can change clinical adoption, regulatory review and reimbursement — all of which affect revenue and growth potential.

metallic artifact reduction medical

Metallic artifact reduction is a set of imaging techniques and software tools used to minimize distortions and streaks that metal implants or surgical hardware cause in CT and MRI scans. For investors, it matters because better artifact reduction improves diagnostic reliability and can increase demand for advanced scanners, software upgrades, and related clinical services—similar to cleaning a foggy window so details behind it become visible and useful.

• First worldwide Allia Moveo installation at Hôpital Marie-Lannelongue in France highlights progress in redefining interventional care delivery
• Allia Moveo combines mobility, versatility and AI-powered tools to help clinicians navigate complex minimally invasive procedures with efficiency and accuracy

CHICAGO--(BUSINESS WIRE)-- GE HealthCare (Nasdaq: GEHC) today announced that Allia™ Moveo has received U.S. Food and Drug Administration (FDA) 510(k) clearance and CE Marking, bringing next-level mobility and precision to the interventional suite. The latest Allia platform, one of the company’s bold innovations first unveiled at the Radiological Society of North America’s (RSNA) 2025 Annual Meeting, assists clinicians in a wide range of 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 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 first medical center in the world to complete the installation of Allia Moveo. The platform is intended to enable flexible cone-beam computed tomography and support this leading 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 the 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.

“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.”

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

• CleaRecon DLⁱ, 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.

Following the first global installation of Allia Moveo at Hôpital Marie-Lannelongue, Houston’s Baylor St. Luke’s Medical Center, a member of CommonSpirit, marked the first installation in the United States.

“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.”

This product may not be available in all regions, contact your GE HealthCare sales representative for more information. To learn more about Allia Moveo, visit https://www.gehealthcare.com/products/image-guiding-solutions/allia-moveo.

*Dr. Stephan Haulon is a paid consultant for GEHC. The statements by Dr. Stephan Haulon described here are based on their own opinions and on results that were achieved in the customer’s unique setting. Since there is no “typical” hospital and many variables exist, i.e. hospital size, case mix, etc. there can be no guarantee that other customers will achieve the same results.

**The statements by Dr. Brad Lembke, described here are based on their own opinions and on results that were achieved in the customer’s unique setting. Since there is no “typical” hospital and many variables exist, i.e. hospital size, case mix, etc. there can be no guarantee that other customers will achieve the same results.

About GE HealthCare Technologies Inc.

GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim 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. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.

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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.

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GE HealthCare Media Contact:

Eric Tatro

GE HealthCare

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Eric.Tatro@gehealthcare.com

Source: GE HealthCare Technologies Inc.