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  • Getting approval for new th...
    Frigerio, Maria

    European respiratory review, 09/2016, Letnik: 25, Številka: 141
    Journal Article

    In the so-called evidence-based medicine (EBM) era, pre-market clinical trials showing equivalent or superior benefit from new drugs versus existing therapies are required by regulatory bodies, while the process for approval of medical devices is less stringent 1. The expansion of device-based therapies for cardiovascular conditions makes cardiology the ideal setting for analysing the peculiarities of this process 2. Lessons learned from cardiology: the process for approval of medical therapeutic devices must be redesigned http://ow.ly/bJPm3017ySH