FDA Paves the Way for Non-Invasive Liver Diagnosis with FibroScan® in MASH Trials
FDA Approves FibroScan® as a Surrogate Endpoint in MASH Clinical Trials
On September 8, 2025, Echosens, a leading innovator in non-invasive liver diagnostics, made headlines with a significant announcement: the U.S. Food and Drug Administration (FDA) officially accepted the company's letter of intent for the qualification of LSM by VCTE (FibroScan®). This pivotal decision positions FibroScan® as a potential non-invasive surrogate endpoint in clinical trials for Metabolic Associated Steatotic Hepatitis (MASH).
A Breakthrough in Liver Disease Management
FibroScan® allows for the measurement of liver stiffness and is a frontier technology in the fight against advanced liver diseases. This method is especially crucial as MASH is a progressive form of fatty liver disease that can escalate to severe conditions such as cirrhosis, liver cancer, or even require transplantation. The FDA's acknowledgment of this method represents a groundbreaking shift in how liver health is evaluated in clinical settings, a move that could eventually reduce the need for more invasive procedures such as liver biopsies.
According to Frank Anania, MD, director of the Hepatology and Nutrition division at the FDA's Center for Drug Evaluation and Research (CDER),
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