• Coalition Protests Aneurysms Treatment Device Approval

    • 02 March 2012
    A patient safety coalition is asking the US Food and Drug Administration (FDA) for more testing into a device that treats complications from aneurysms treatments. According to a report by Qmed, a letter was sent to FDA commissioner Margaret Hamburg urging that the device, the endovascular suturing system, should have been classified as high risk and subjected to more rigorous testing. FDA granted approval after a study involving 10 women and 144 men under the de novo pr...