GAITHERSBURG, Maryland — Thursday's meeting of the circulatory systems advisory committee made clear again how much detail FDA seeks in its regulation of high-risk medical devices. FDA convened the panel for ideas about what should be required for a clinical trial for a cardiac anti-adhesion device in adult populations, but the feedback was not as extensive as the agency may have hoped. (Medical Device Daily)

GAITHERSBURG, Maryland — The circulatory systems advisory committee met Wednesday to discuss an application for a humanitarian device exemption (HDE) for the Melody pulmonary valve, a prosthetic replacement of bovine origin made by Medtronic (Minneapolis). The final vote was hardly a squeaker, with the application wining a unanimous vote for approvability, but a series of concerns peppered the panel's discussions, including the issue of stent fragmentation. (Medical Device Daily)