GE Healthcare secures FDA clearance for cardiovascular system

GE Healthcare has secured 510k clearance from the Food and Drug Administration (FDA) for its Ultra Edition package of Vivid cardiovascular ultrasound systems. The Vivid Ultra Edition includes new features based on artificial intelligence (AI) to enable clinicians to obtain quick and more repeatable exams with consistency. It delivers improved efficiency to the scanning process by providing reduced exam time through up to 80% fewer clicks, 99% accuracy and lower inter-operator variability. A methodical evaluation of heart function is considered vital in echocardiography while high-quality data acquisition and operator skills are important elements to obtain accurate and complete exams. Utilising AI-driven, neural network-based algorithms, Vivid Ultra Edition features enable repeatable and faster measurements in 2D echo imaging.