FDA Clears Emerging CT Device That Facilitates 50 Percent Reduction in CCTA Exam Time

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Revolution Vibe computed tomography (CT) system, which reportedly enhances efficiency with coronary CT angiography (CCTA) exams.

Unveiled earlier this year at the American College of Cardiology (ACC) conference, the Revolution Vibe CT platform has an Effortless Workflow feature that reduces CCTA exam time by 50 percent, according to GE HealthCare, the manufacturer of the device.

In addition to a variety of artificial intelligence (AI) tools to aid in automated protocol selection and easier patient positioning, GE HealthCare noted the Revolution Vibe CT system offers One-Beat Cardiac imaging, which provides efficient low-dose imaging clarity, even for patients that do not have an electrocardiogram (ECG) trace.

The company emphasized the capability of the Revolution Vibe CT system for improving CCTA assessments of patients with heavily calcified coronaries, arrhythmias and stents.

“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,” noted Jean-Luc Procaccini, the president and CEO of molecular imaging and computed tomography for GE HealthCare.