FDA Clears Echosens FibroScan® Non-Invasive Liver Diagnosis System

Echosens FibroScan for Non-invasive Liver Diagnosis

In short

Paris-based Echosens™ has announced that its FibroScan® liver disease detection device has received FDA 510(k) clearance. The company says it is now ready to market its pioneering technology in the United States.

Background

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

With more than 660 peer-reviewed publications, FibroScan® is by far the elastography device with the largest body of evidence on its clinical usefulness. Moreover, the use of FibroScan® is also mentioned in guidelines and recommendations in different regions of the world: World Health Organization, European Association for the Study of Liver (EASL), Asian Pacific Association for the Study of Liver (APASL), etc.

FibroScan® is manufactured by Echosens™ (Paris, France). Since its foundation in 2001, Echosens™ has gathered strong leadership in quantitative elastography. Very active in research and development, Echosens™ holds 17 patent families mainly focused on its core technology: Vibration-Controlled Transient Elastography (VCTE™)

Source: Echosens, PR Newswire

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