FDA Approves FibroScan for Noninvasive Liver Diagnosis

April 16, 2013 — Echosens has announced its FibroScan device received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

Today, 1800 FibroScan devices are used worldwide both in research and routine clinical practice. The United States is the last major market to approve FibroScan.

FibroScan is used in the clinical management of patients with liver disease such as chronic viral hepatitis C and B and fatty liver diseases. Based on a technology called transient elastography, FibroScan assesses liver shear wave speed (expressed in meter per second) and equivalent stiffness (expressed in kilopascal) at 50 Hz in a rapid, simple, non-invasive and totally painless way.

Initially introduced in the European market in 2003, FibroScan pioneered the quantitative elastography medical field. It received market clearances in China (2008), Canada (2009), Brazil (2010), Japan (2011) and is currently available in 70 countries.

For more information: www.echosens.com