Getting approval for new therapeutic medical devices versus drugs: are the differences justified?

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].