REQUEST FOR INFORMATION (RFI) Non-Invasive Transient Elastography Device NOTICE OF ACTION: This is a Request for Information (RFI) Only.

FibroScan® utilizes Vibration-Controlled Transient Elastography (VCTE) technology that appears to be the approach of choice to determine the degree of fibrosis. This has been validated in over 1,200 publications on the various aspects of effectiveness, efficacy, and accuracy of VCTE to help aid Physicians in their treatment of Liver Disease.

FibroScan® utilizes Vibration-Controlled Transient Elastography (VCTE) technology that appears to be the approach of choice to determine the degree of fibrosis. This has been validated in over 1,200 publications on the various aspects of effectiveness, efficacy, and accuracy of VCTE to help aid Physicians in their treatment of Liver Disease.

The FibroScan will monitor and detect hepatic steatosis and by utilizing transient elastography to identify veterans with Nonalcoholic Fatty Liver Disease (NAFLD) and significant fibrosis. The system will also assist in guiding HCV anti-viral therapy based on the fibrosis status. Determine the need for HCC surveillance before and after SVR. Monitor fibrosis progression in treatment naïve or failure veterans who cannot undergo treatment.

The FibroScan will monitor and detect hepatic steatosis and by utilizing transient elastography to identify veterans with NAFLD and significant fibrosis. The system will also assist in guiding HCV anti-viral therapy based on the fibrosis status. Determine the need for HCC surveillance before and after SVR. Monitor fibrosis progression in treatment naà ̄ve or failure veterans who cannot undergo treatment. Monitor fibrosis regression after SVR.

The unit shall be capable of Vibration Controlled Transient Elastography (VCTE) for non-invasive measurement of liver fibrosis and cirrhosis. The unit shall be capable of diagnosis and surveillance of chronic liver diseases, such as Hepatitis B, Hepatitis C, Autoimmune Hepatitis and Fatty Liver Disease, by utilizing VCTE to measure shear wave velocity passing through liver tissue.