FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management
The U.S. Food and Drug Administration (FDA) has cleared expanded Indications for Use for screening with FibroScan®, the non-invasive liver management technology by Echosens.
The update furthers FibroScan® accessibility to more people, enabling physicians to identify those at risk of suffering adverse liver outcomes and connecting them with preventative care and treatment options.
The new clearance removes contraindications for pregnancy and active implants and includes the following:
- FibroScan may aid the physician in determining the likelihood of cirrhosis and in the assessment of liver fibrosis and hepatic steatosis.
- Designates FibroScan as a non-invasive aid for the clinical management, diagnosis, and monitoring of adult and pediatric patients with confirmed or suspected liver disease as part of an overall assessment of the liver.
- The patient population has been expanded from “patients with liver disease” to “patients with confirmed or suspected liver disease.”
- Age has been removed as the first selection probe and exam-type step.
- Measurement interpretation has been expanded to all physicians with appropriate training.
- The removal of “estimates of” when referring to tissue stiffness.
“These updated Indications of Use are another proof point for screening with FibroScan to become commonplace in the clinical care pathway,” said Jon Gingrich, CEO of Echosens. “Expanding the usage of FibroScan equipment to a larger patient population allows physicians to diagnose and manage suspected liver disease in earlier stages and provide a better quality of care.”
The FibroScan device can be used to predict the risk of disease progression and decompensation, guide management decisions, evaluate response to treatment, and significantly reduce the need for a biopsy.
For more information on products in the FibroScan® range, please visit https://www.echosens.com/fibroscan.
Pioneer in its field, Echosens significantly changed the practice of liver assessment with FibroScan®, the non-invasive solution for comprehensive management of liver health. For the past decade, FibroScan® has been recognized worldwide and validated by over 3,500 peer-reviewed publications and 160 international guidelines. Echosens has made FibroScan® available in over 100+ countries enabling millions of liver examinations worldwide. https://www.echosens.com/
See Full Press Release at the Source: FDA Expands Indications for Use of FibroScan® for Comprehensive Liver Management
Press Release by: Echosens
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