16 April 2013 | Regulatory | By BioSpectrum Bureau
Echosens gets US FDA nod liver diagnosis device FibroScan
Singapore: US FDA has given marketing approval to Paris-based Echosens' non-invasive liver diagnosis device, FibroScan. The device is used worldwide both in research and routine clinical practice.
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 during 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.