Tag:
FDA expert panel
Latest Headlines
Latest Headlines
FDA panel to evaluate HeartWare International's blood pump
HeartWare International's blood pump and Cameron Health's under-the-skin defibrillator go before an FDA panel of experts this week whose recommendation could make or break their chances for marketing approval.
FDA panel to hear experts, patients on metal hips
The FDA is seeking expert feedback on the risks and potential benefits of metal-on-metal hips.
FDA: J&J, others must study safety of vaginal mesh
The FDA is ordering the makers of vaginal mesh implants to study the rates of organ damage and other complications following allegations that the devices have harmed women. The devices are used to...
Panel mulls tougher rules for transvaginal meshes
Makers of vaginally implanted surgical meshes, including Johnson & Johnson ( $JNJ ), Endo Pharmaceuticals Holdings and C.R. Bard, could eventually be required to initiate studies on their products
FDA panel votes in favor of Sapien valve
The FDA's Circulatory System Devices Committee gave Edwards Lifesciences ( $EW ) a win Wednesday with a vote recommending the devicemaker's Sapien transcatheter heart valve after an epic session. The
FDA sees promising Edwards valve as safe, effective
An FDA report released Monday showed that Edwards Lifesciences' Sapien heart valve, which can be implanted without major surgery, significantly reduced rates of death versus standard therapy in
FDA panel to review Edwards SAPIEN valve next month
Edwards Lifesciences has announced that an FDA advisory panel is scheduled to review the company's PMA application for its Edwards SAPIEN transcatheter heart valve on July 20. Edwards submitted the
FDA panel advises more testing for ECT devices
An expert FDA panel has determined that electroconvulsive therapy (ECT) machines should undergo the same rigorous testing as new medical devices. The Neurological Devices Advisory Committee held no
FDA makes changes to expert panels
An ever-increasing number of FDA expert panels has prompted the agency to change the way it conducts premarket medical device reviews. According to the FDA's Center for Devices and Radiological
