French medical device maker Echosens said the FDA granted 510(k) clearance for its FibroScan device for evaluating liver function in patients with liver disease
The federal watchdog agency’s nod marks the final major market approval for FibroScan, according to Echosens.
Paris-based Echosens said it introduced the FibroScan elastography device in Europe in 2003 and has since won approvals in 70 countries, including China, Canada, Brazil and Japan.