The U.S. Food and Drug Administration (FDA) has cleared ultrasound technology developer SuperSonic Imagine's Aixplorer and Aixplorer Ultimate ultrasound scanners for clinical management of patients with liver disease.
This clearance covers specific ultrasound imaging capabilities related to liver disease, and will allow clinicians to use Aixplorer to assess hepatic fibrosis and steatosis, the company said.
Aixplorer systems image and measure liver and spleen stiffness in real time under image guidance, using SuperSonic Imagine's shear-wave elastography technology. Liver and spleen stiffness are known to be correlated to liver fibrosis severity and are therefore considered key noninvasive markers of disease severity, according to the firm.
