FibroScan® Approved Indications

The intended use for the FibroScan family of products.

The FibroScan Intended Use

The intended use/indications for use for the FibroScan are as follows:

The FibroScan Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is intended to provide 50Hz shear wave speed measurements and estimates of tissue stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP™: Controlled Attenuation Parameter) in internal structures of the body.

FibroScan Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is indicated for noninvasive measurement in the liver of 50 Hz shear wave speed and estimates of stiffness as well as 3.5 MHz ultrasound coefficient of attenuation (CAP: Controlled Attenuation Parameter).

The shear wave speed and stiffness, and CAP may be used as an aid to diagnosis and monitoring of adult patients with liver disease, as part of an overall assessment of the liver.

Shear wave speed and stiffness may be used as an aid to clinical management of pediatric patients with liver disease.

Additionally, the FibroScan technology complies with all applicable rules governing the level of energy applied and absorbed to the human body, including mechanical indexes and heat dissipation.

Clinical Practice Guidelines

FibroScan, patented VCTE™ technology is the reference for the non-invasive assessment of liver disease in many internationally recognized treatment guidelines, across specific etiologies of Liver Disease.

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Clinical Practice Guidelines

Guidelines
Etiology of Liver Disease
Reference
Downloads / More Information
ADA
TD2M
New recommendations for evaluations of liver health in TD2M patients. ADA: Standards Of medical Care in Diabetes - 2019
AASLD
NAFLD
Diagnosis and Management of Nonalcoholic Fatty Liver Disease: Practice Guidance from the American Association for the Study of Liver Diseases
AGA Guidelines
HCV, HBV
Institute Technical Review on the Role of Elastography in Chronic Liver Diseases
AASLD/IDSA
HCV
Recommendations for Testing, Managing and Treating Hepatitis C; When & In Whom to Initiate Antiviral Therapy, AASLD & IDSA Practice Guidelines
EASL
HCV
EASL Clinical Practice Guidelines: Noninvasive Tests for Evaluation of Liver Disease Severity and Prognosis; Journal of Hepatology 2015
EASL, EASD, EASO
NASH
Journal of Hepatology 2016 vol 64/1388-1402
WHO
HCV
WHO Guidelines for Screening, Care and Treatment of Persons with Hepatitis C Infection; ISBN 978 92 4 154875 5
WHO
HBV
Guidelines for the prevention, care, and treatment of persons with chronic hepatitis B infection. 2015 WHO Algorithm of WHO recommendations of the Management of Persons with Chronic Hepatitis B infection (Page xxvi)
WHO
HCV & Co-infection
Management of HCV & HIV co-infection WHO 2012 HIV/AID treatment. Clinical Protocol for the WHO European Region Chapter 6
NICE (UK)
HCV
Diagnosis and Management of Chronic Hepatitis B in Children, Young People OR Adults

These references represent uses of FibroScan in published literature. Echosens does not intend to make any of the specific claims found in these articles. FibroScan is a tool to aid in the clinical management of liver disease, and is not intended for the treatment of any specific liver disease or condition.

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