TY - JOUR T1 - Getting approval for new therapeutic medical devices <em>versus</em> drugs: are the differences justified? JF - European Respiratory Review JO - EUROPEAN RESPIRATORY REVIEW SP - 223 LP - 226 DO - 10.1183/16000617.0037-2016 VL - 25 IS - 141 AU - Maria Frigerio Y1 - 2016/09/01 UR - http://err.ersjournals.com/content/25/141/223.abstract N2 - 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 ER -