GE HealthCare (Nasdaq: GEHC) announced that it received FDA 510(k) clearance for its Revolution Vibe CT imaging system.
Chicago-based GE HealthCare designed the system to elevate the practice of coronary CT angiography (CCTA). It features unlimited one-beat cardiac imaging and integrated AI-powered tools. The company says it offers clinicians a fast, powerful and non-invasive way to identify potential heart blockages. It achieves this while enhancing patient comfort and streamlining workflow.
The system is engineered to address the most difficult cardiac exams, the company says. Those include patients with arrhythmias, heavily calcified coronaries and valves, stents or bypasses. The system’s unlimited one-beat cardiac imaging delivers full-heart clarity at low dose, even in cases without an ECG trace.
Features include ECG-less Cardiac, TrueFidelity DL, SnapShot Freeze 2 and Effortless Cardiac Workflow optimize image quality and reduce exam time, the company says. It helps to make cardiac CT more accessible and efficient.
GE HealthCare said FDA clearance for the system paves the way for broader adoption across U.S. facilities. In addition to FDA clearance, the company announced the system’s first adoption abroad as well. Radiologie du Var – ELSAN in Ollioules, France, became the first healthcare system in the world to install the technology.
“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,” shares 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.”
