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GE Healthcare Announces U.S. FDA 510k Clearance for its Ultra Edition Package on Vivid Cardiovascular Ultrasound Systems

October 12, 2020 / Holly Roloff
SHARESHARESHARE

GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious and time-consuming to acquire. High quality data acquisition and operator skill are key elements to achieve accurate and complete exams. And, as patients undergo subsequent monitoring exams, the reproducibility of exam assessments is key to identifying improvement or disease progression. Vivid Ultra Edition brings increased efficiencies to the scanning process for reduced exam time through up to 80% fewer clicks3, 99% accuracy4 and less inter-operator variability.