- 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®.
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™).
FDA regulations are not about the cost of the product. They are about the safety. At least in theory. For some reason there was no push from the lobby to act faster. Who would actually push for it unless there was a financial gain. Maybe the gain isn't that great. So if there was no pressure-it took forever. That could be one explanation. So it could be about money at the end,after all.:)
When, while back, I spoke to my doctor about the popularity of the Fibroscan, he told me that the accuracy of the test result is a concern among the doctors here,combined with the healthcare system (in America), where so much is up to the insurance companies regarding the coverage.
It is because of the forums like this they approve it.
As for US it is a sad fact that healthcare is a business that first and most protects the interests of special interest groups with big money. Drug, insurance and doctors lobby who are just as guilty as the first too because they go along with this system. And accept gift. Payed vacation trips and even rolex watches.
As for FDA dont really blame them. It is a government organization that bases decisions based on the experts they contract or that work for them that also can be associated with the drug and insurance companies at the same.and accept those same contributions from the last two.
In general this is the problem with america. It is runned by special interest Groups if you look at the many laws set up protecting .big corporations interests. And health care is no different. If insurance companies still are allowed to discriminate patients with preexisting conditions. Impose treatments caps and deny medical services. So in a way us sick people have to endure medical apartheid or eugenics.
So what I getting at here there is a much bigger picture with US healthcare then lack of fibroscan or surface antigen. It is a moral.problem this society faces where healthcare is for profit only.
Ideally we need them both. CT can detect tiny tumors or lesions while fibroscan measures elasticity of the liver.
A PET scan can now amplify even cancerous sells. Some researchers say they have even amplified HiV particles. But health insurance companies are reluctant to pay for it unless there is a cancer diagnose.
But CT is good to do. Just make sure it is done on a latest low radiation machine so you get minimal exposure to it of about equal to several xrays.
it is also necessary to avoid contrast liquids because they do damage kidneys, after the use of these liquids there is kidneys disfunction with high creatinine and low creatinine clearance for few weeks.the use of nac can shorten or avoid this damage
while this damage can be ok in case of tumors i dont think this is justify for prevention.i was suggested to do it but instead i used very high sensibility ultrasound.ct scan without contrast liquid is also ok it works anyway at a less sensibility level which is ok for simple prevention
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