French ultrasound technology developer Echosens has received U.S. Food and Drug Administration 510(k) clearance for its FibroScan ultrasound elastography system.
Designed for noninvasive liver diagnosis, FibroScan is used in the clinical management of patients with liver disease, such as chronic viral hepatitis C and B, as well as fatty liver diseases, according to the vendor. The system uses transient elastography technology to assess liver shear-wave speed (in meters per second) and equivalent stiffness (in kilopascal) at 50 Hz, Echosens said.
The U.S. is the last major market to approve FibroScan; 1,800 FibroScan devices are currently in use worldwide, both in research and routine clinical practice, the company said.
