FDA Approves FibroScan for Non-invasive Liver Diagnosis

Tue Apr 16, 2013 9:00am EDT

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PARIS,  April 16, 2013  /PRNewswire/ --



- Echosens is pleased to announce that FibroScan 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 devices are used worldwide both in research and routine
clinical practice.  The United States of America  is the last major market to
approve FibroScan.

     (Logo:  http://photos.prnewswire.com/prnh/20130415/607780-a  )

     (Photo:  http://photos.prnewswire.com/prnh/20130415/607780-b  )



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.

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).

Contact Echosens:

Aurélie Houet, Communication Manager

Tel: +33-1-44-82-78-50

Email:  aurelie.houet@Echosens.com
http://www.echosens.com



 

SOURCE  Echosens

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