FDA clears SuperSonic Imagine ultrasound systems for liver application

SuperSonic Imagine of Aix-en-Provence, France, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aixplorer® and Aixplorer® Ultimate ultrasound diagnostic systems to be used as aids for the assessment of hepatic fibrosis and steatosis of patients with liver disease.

The company states that in addition to performing routine morphological and hemodynamic imaging, the ultrasound systems can rapidly and reliably image and measure liver and spleen stiffness in real time under image guidance using its ShearWave™ Elastography (SWE) technology. The Aixplorer systems can also be used to compare ultrasound liver brightness to a reference tissue and to arrive at a hepato-renal brightness ratio indicating the extent of hepatic steatosis. The systems’ ability to visualize and quantify abdominal vascularization and perfusion will assist in the clinical management of patients with liver nodules and advanced chronic liver diseases, according to SuperSonic Imagine.