FDA Approves FibroScan(R) for Non-invasive Liver Diagnosis
PARIS, April 16, 2013 /PRNewswire/ –
– Echosens(TM) is pleased to announce that FibroScan(R) device received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) on April 5th, 2013 and is now
ready to market its pioneering technology in the United States.
Today, 1800 FibroScan(R) devices are used worldwide both in research and routine
clinical practice. The United States of America is the last major market to approve
FibroScan(R) 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(R) 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(R) 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.
With more than 660 peer-reviewed publications, FibroScan(R) is by far the elastography
device with the largest body of evidence on its clinical usefulness. Moreover, the use of
FibroScan(R) 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(R) is manufactured by Echosens(TM) (Paris, France). Since its foundation in
2001, Echosens(TM) has gathered strong leadership in quantitative elastography. Very
active in research and development, Echosens(TM) holds 17 patent families mainly focused
on its core technology: Vibration-Controlled Transient Elastography (VCTE(TM)).
Contact Echosens(TM): Aurelie Houet, Communication Manager Tel: +33-1-44-82-78-50 Email: aurelie.houet@Echosens.com http://www.echosens.com
Photo: http://photos.prnewswire.com/prnh/20130415/607780-a http://photos.prnewswire.com/prnh/20130415/607780-b