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GEHC Wins FDA Clearance & CE Mark for Allia Moveo, Marks Global Debut

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Key Takeaways

  • GEHC secures FDA 510(k) clearance and CE Mark for Allia Moveo, enabling commercialization.
  • Allia Moveo's compact, cable-free design and AI-enabled guidance aim to boost workflow efficiency.
  • GEHC reports first global installation in France and initial U.S. deployment, supporting vascular procedures.

GE HealthCare Technologies Inc. (GEHC - Free Report) recently announced that it has obtained FDA 510(k) clearance and CE Marking for its Allia Moveo, enabling commercialization of its latest interventional imaging platform in the United States and Europe. The mobile C-arm platform — introduced at RSNA 2025 — expands the Allia portfolio and is designed for use across cardiovascular, vascular, non-vascular, interventional and surgical applications. Allia Moveo incorporates a compact, cable-free design, an intuitive user interface and AI-enabled guidance features, which are intended to improve procedural workflow efficiency and address space limitations found in interventional suites.

Allia Moveo has already marked its first global installation at Hôpital Marie-Lannelongue in France — a leading center for thoracic, vascular and cardiac surgery — with Baylor St. Luke’s Medical Center completing the first installation in the United States. The system is designed to support cone-beam CT imaging and facilitate the treatment of vascular and cardiology conditions. Its ergonomic and highly maneuverable design aims to broaden patient accessibility across a range of body sizes, incorporating a wide-bore configuration and simplified table movement to enhance procedural access and comfort.

Per management, Allia Moveo is designed to simplify clinical workflows, enhance procedural control and improve the overall clinician experience within the interventional suite. GEHC’s collaboration with Hôpital Marie-Lannelongue on the system’s first global installation is an important milestone for the Allia platform and reflects the company’s broader focus on developing clinically relevant innovations that support care teams and patient outcomes.

Likely Trend of GEHC Stock Following the News

Following the announcement, shares of GEHC gained 1.4% at yesterday’s closing. Over the past six months, shares of the company have climbed 13.4% against the industry’s 9.4% decline. However, the S&P 500 has risen 12.4% during the same time frame.

In the long run, regulatory clearance and early installations of Allia Moveo expand GEHC’s addressable market in interventional imaging and reinforce its competitive position. The first global and United States installations validate clinical adoption and execution capability, while differentiated features such as AI-enabled imaging, workflow efficiency and compact design enhance the company’s ability to deliver high-value systems. As interventional procedures continue to grow, Allia Moveo supports GEHC’s innovation pipeline and underpins long-term growth driven by demand for advanced, minimally invasive procedural solutions.

GEHC currently has a market capitalization of $35.97 billion.

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More on Allia Moveo

A major differentiator of Allia Moveo is its advanced 3D imaging and AI-enabled guidance capabilities intended to support anatomical visualization and clinical decision-making. The platform integrates CleaRecon DLi, an AI-based reconstruction technology designed to reduce streak artifacts associated with arterial blood flow and Motion Freeze, which mitigates image degradation from involuntary respiratory motion. The system also includes metallic artifact reduction to improve visualization in the presence of implants or instruments. In addition, Allia Moveo supports augmented procedural guidance through GEHC’s ASSIST advanced clinical applications portfolio and is compatible with select GE HealthCare and third-party systems.

The early adoption by Hôpital Marie-Lannelongue and Baylor St. Luke’s Medical Center provides important validation from high-profile centers of excellence. Stephan Haulon,vascular surgeon at Hôpital Marie-Lannelongue noted that Allia Moveo enables rapid system positioning and procedural flexibility. AI-based CleaRecon DL cone-beam CT reconstruction is a key advancement, citing improved image quality that may enhance clinical confidence during complex vascular interventions. According to Baylor St. Luke’s Medical Center leadership, the platform’s mobility, imaging performance and workflow efficiency are expected to support complex minimally invasive procedures and align with the hospital’s focus on precision and patient-centered care.

For GE HealthCare, Allia Moveo represents a meaningful evolution, as procedural complexity increases and clinicians require high-quality imaging systems to support workflow efficiency and seamless technology integration. Allia Moveo is developed in collaboration with clinicians to address space and usability constraints, offering a high-performance, easy-to-use platform designed for demanding interventional environments.

Industry Prospects Favoring the Market

Going by data provided by Precedence Research, the interventional radiology market is anticipated to be valued at $31.44 billion in 2026 and is expected to witness a CAGR of 4.9% through 2034. Factors like the rising prevalence of chronic diseases such as cardiovascular, oncology and gastroenterology, etc., the growing preference for minimally invasive treatments, technological advancements in imaging and interventional devices and the expansion of healthcare infrastructure and early disease detection initiatives are driving the market’s growth.

Other News

GE HealthCare received FDA 510(k) clearance for MIM LesionID Pro, an AI-enabled software solution designed to streamline whole-body tumor burden analysis for PSMA PET/CT and SPECT/CT studies. The tool aims to reduce physician workload, support radiopharmaceutical therapy assessment and facilitate treatment response monitoring.

GE HealthCare announced a collaboration with NXP Semiconductors to develop edge AI solutions for acute care applications, targeting anesthesiology and neonatal use cases. The partnership leverages NXP’s edge processing capabilities and GEHC’s clinical expertise, with early concepts presented at CES 2026 to support workflow efficiency and clinical decision-making.

GEHC’s Zacks Rank & Key Picks

Currently, GEHC has a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Veracyte (VCYT - Free Report) , AtriCure (ATRC - Free Report) and Boston Scientific (BSX - Free Report) .

Veracyte, sporting a Zacks Rank #1 (Strong Buy) at present, reported third-quarter 2025 adjusted earnings per share (EPS) of 51 cents, which surpassed the Zacks Consensus Estimate by 59.4%. Revenues of $131.8 million beat the Zacks Consensus Estimate by 5.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

VCYT has an estimated earnings recession rate of 3% for 2026 compared with the industry’s 17.5% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 45.1%.

AtriCure, currently carrying a Zacks Rank #2 (Buy), reported a third-quarter 2025 adjusted loss per share of 1 cent, narrower than the Zacks Consensus Estimate by 90.9%. Revenues of $134.3 million beat the Zacks Consensus Estimate by 2.1%.

ATRC has an estimated earnings growth rate of 91.7% for 2026 compared with the industry’s 17.7% rise. The company beat earnings estimates in the trailing four quarters, the average surprise being 67.1%.

Boston Scientific, currently carrying a Zacks Rank #2, reported a third-quarter 2025 adjusted EPS of 75 cents, which surpassed the Zacks Consensus Estimate by 5.6%. Revenues of $5.07 billion beat the Zacks Consensus Estimate by 1.9%.

BSX has an estimated long-term earnings growth rate of 16.4% compared with the industry’s 13.1% growth. The company’s earnings beat estimates in each of the trailing four quarters, the average surprise being 7.4%.

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