The 510k clearance for Echosense marks the last major market to approve the FibroScan device. The Paris, France-based medical device company first introduced the FebroScan in Europe in 2003, and it has since won approvals in 70 countries.
FibroScan is a clinical management device for patients with liver disease, and it uses a technology called transient elastography to measure the liver’s shear wave speed and equivalent stiffness. More than 1800 devices are used worldwide, according a company statement.