GE Healthcare has received FDA 510(k) clearance for the latest version of its built-for-4D Vivid E9 cardiovascular ultrasound system.
According to the company, Vivid E9 features a multislice acquisition technology with the ability to acquire images of up to 12 slices of the heart, and automated function imaging (AFI) for tri-plane measurements. The ultrasound also includes new quantification tools including 4D strain, 2D auto ejection fraction and AFI for transesophageal echocardiogram, for left ventricular, global and regional function. The system has a new high bandwidth 4V-D transducer and a new 12S-D transducer for neonatal patients.
Vivid E9 is now FDA cleared, CE marked and is also available for sale in many Asian and South American countries.