Echosens has announced that FibroScan device received 510(k) clearance from the US Food and Drug Administration (FDA) on 5 April 2013 and is preparing to market its technology in the USA.
Today, 1800 FibroScan devices are used worldwide both in research and routine clinical practice. The USA is the last major market to approve FibroScan, according to a company release.
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 metre per second) and equivalent stiffness (expressed in kilopascal) at 50Hz 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.
According to the company, the use of FibroScan is also mentioned in guidelines and recommendations in different regions of the world such as the World Health Organisation, European Association for the Study of Liver (EASL), and Asian Pacific Association for the Study of Liver (APASL).