GE HealthCare Secures FDA Clearance for Revolution™ Vibe CT System, with First Global Installation in France
GE HealthCare has announced that its latest innovation in advanced medical imaging, the Revolution™ Vibe CT system, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance marks a significant milestone for the company, enabling broader adoption of the cutting-edge CT technology across the United States while also underscoring its role as a pioneer in advancing cardiac imaging worldwide. The very first global installation of the Revolution Vibe has already taken place at Radiologie du Var – ELSAN in southern France, a facility recognized for its high cardiovascular imaging volumes and leadership in innovation.
Addressing the Growing Burden of Cardiovascular Disease
Cardiovascular disease (CVD) remains a leading health challenge globally and is projected to account for more than 23 million deaths each year by 2030. Non-invasive cardiac imaging, especially coronary CT angiography (CCTA), is gaining greater clinical recognition and demand as physicians seek more precise and patient-friendly ways to diagnose heart disease early. With this trend accelerating, healthcare providers need systems that are not only capable of producing highly accurate images but also efficient enough to meet rising patient volumes.
GE HealthCare’s Revolution Vibe has been designed specifically with this need in mind. The system integrates Unlimited One-Beat Cardiac imaging with AI-powered workflow enhancements to deliver fast, reliable, and non-invasive identification of potential coronary blockages. This allows physicians to make confident decisions while also improving patient comfort, reducing exam complexity, and streamlining operations within imaging departments.
Leadership Perspective
“Revolution Vibe’s FDA clearance comes at the perfect time,” said Jean-Luc Procaccini, President and CEO of Molecular Imaging and Computed Tomography at GE HealthCare. “As clinical guidelines increasingly support the use of cardiac CT and reimbursement conditions drive growth in these procedures, it is essential to offer a system that can handle even the most complex cases. Revolution Vibe empowers clinicians to detect coronary artery disease, plan interventions, and improve diagnostic confidence, while also reducing exam time and contributing to better outcomes.”
Advanced Capabilities Designed for Complex Cases
The Revolution Vibe is engineered to perform even under the most demanding clinical conditions. Patients with arrhythmias, extensive calcification, prior stents, or bypass surgeries often pose imaging challenges. With Unlimited One-Beat Cardiac imaging, the system delivers full-heart clarity at low radiation doses, even in cases where traditional ECG trace data is unavailable.
Some of the key innovations include:
- ECG-less Cardiac Imaging – Eliminating the dependency on complex ECG setup.
- TrueFidelity™ Deep Learning (DL) – Advanced image reconstruction powered by AI.
- SnapShot Freeze 2 – Reduces motion artifacts for clearer results.
- Effortless Cardiac Workflow – Simplifies preparation and exam processes, enabling more efficient patient throughput.
Clinical evaluations have already demonstrated significant efficiency gains. With Effortless Workflow, Revolution Vibe reduced exam time by up to 50% and saved as much as five minutes per scan during patient preparation. Facilities also reported improved scheduling flexibility, with CCTA capacity effectively doubling due to streamlined protocols and reduced reliance on beta blockers and ECG connections.
First Global Installation in France
The first healthcare institution in the world to install Revolution Vibe is Radiologie du Var – ELSAN, located in the Toulon region of southern France. The institution operates across three major sites: Polyclinique Les Fleurs, Clinique du Cap D’Or, and Clinique Saint-Michel. Known for performing some of the highest volumes of cardiovascular imaging in France, Radiologie du Var – ELSAN has long been at the forefront of adopting breakthrough imaging solutions.
“With Revolution Vibe in our fleet, we feel better prepared to meet the rising demand for cardiac imaging,” said Sébastien Saint Germain, Director of Radiologie du Var – ELSAN. “In just the first weeks of use, its AI-driven workflow and advanced imaging capabilities have already enabled us to deliver faster, more confident diagnoses for patients. This technology represents the beginning of a new era in cardiac CT.”
The facility now operates ten advanced imaging systems, including 1.5T and 3T MRIs, a spectral scanner, and other modalities, all networked to ensure patients receive the right test at the right time. This approach reflects the organization’s mission to provide comprehensive, timely care across a range of medical conditions.
Expanding Beyond Cardiac Imaging
While Revolution Vibe has been celebrated for its cardiac imaging strengths, the system also extends its capabilities to general imaging applications. This allows healthcare providers to expand their service lines, optimize resource utilization, and balance lifecycle costs more effectively. In addition, GE HealthCare has emphasized the system’s energy-efficient design and Smart Subscription options, which include fleet management support and extensive training resources to ensure long-term value.
