GE HealthCare Revolution Vibe CT system gets USFDA clearance
Chicago: GE HealthCare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Revolution Vibe CT system, an imaging solution designed to elevate the practice of coronary CT angiography (CCTA).
With Unlimited One-Beat Cardiac imaging and integrated AI-powered tools, Revolution Vibe offers clinicians a fast, powerful, and non-invasive way to identify potential heart blockages while enhancing patient comfort and streamlining workflow, the company claimed.
Cardiovascular disease (CVD) remains the leading cause of death globally, with projections estimating over 23 million deaths annually by 2030.
“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.”
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