The U.S. Food and Drug Administration (FDA) has ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study for the permanent birth control device. The purpose of the study is “to provide important information about the risks of the device in a real-world environment.” Essure is a permanent birth control method...
FDA Approves Olympus Scope Modifications Intended to Reduce Infection Risk
On January 15, 2016, the U.S. Food and Drug Administration (FDA) cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. (1/15/16 FDA News Release) Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed...