GE HealthCare’s Revolution Vibe CT receives FDA clearance
GE HealthCare has secured FDA 510(k) clearance for its Revolution Vibe CT system, a cardiac imaging platform designed to capture full-heart clarity in a single beat without requiring electrocardiogram trace. The system addresses growing demand for coronary CT angiography (CCTA) as cardiovascular disease continues to account for projected annual deaths exceeding 23 million globally by 2030.
GE HealthCare’s Revolution Vibe CT
First global installation completed in France
Radiologie du Var – ELSAN in Ollioules, France, has become the first healthcare facility worldwide to install the technology. The imaging provider operates across three sites in the Toulon region and performs one of the highest volumes of cardiovascular imaging in France. “With Revolution Vibe in our fleet, we feel better prepared to meet growing demand for cardiac imaging and are proud to offer a fast, noninvasive diagnostic solution to our patients,” said Sébastien Saint Germain, Director of Radiologie du Var – ELSAN.
Clinical performance demonstrates workflow efficiency gains
Clinical evaluations of Revolution Vibe with Effortless Workflow showed a 50% reduction in exam time and up to five minutes saved in patient preparation per scan. The system doubled CCTA capacity through optimised exam scheduling, driven by automated protocol selection, simplified positioning, and reduced reliance on beta blockers and ECG connections.
The platform’s Unlimited One-Beat Cardiac imaging capability delivers diagnostic-quality images at low radiation dose, targeting complex cases including patients with arrhythmias, heavily calcified coronaries and valves, stents, or bypasses. Integrated artificial intelligence tools including ECG-less Cardiac, TrueFidelity DL, SnapShot Freeze 2, and Effortless Cardiac Workflow combine to enhance image quality whilst streamlining examination protocols.
Addressing cardiac imaging demands
“Revolution Vibe’s FDA clearance comes at the perfect time, with guidelines being adopted clinically for cardiac CT and with positive reimbursement driving procedure growth, this is the time to usher in a new era of cardiac imaging,” said Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography, GE HealthCare. “Designed to help clinicians detect coronary artery disease and help plan valvular heart interventions quickly and confidently – even in complex cases – Revolution Vibe offers a practical, high-performance solution to help improve diagnostic accuracy, reduce exam time, and support better patient outcomes.”
Broader imaging applications supported
Beyond cardiac applications, Revolution Vibe supports general imaging requirements and includes energy-efficient design features, Smart Subscription services, fleet management capabilities, and comprehensive training programmes. The system aims to help facilities expand service lines whilst managing lifecycle costs through its integrated technology platform.
- For more information, visit: https://www.gehealthcare.com/products/computed-tomography/revolution-family/revolution-vibe
