510(k)
Neuronetics’ depression therapy device wins CE Mark | Regulatory Roundup
ViewRay touts FDA’s OK for MRI guided radiotherapy | Regulatory Roundup
Medigus lands FDA win for gastroesophageal reflux treatment device | Regulatory Roundup
HeartWare lands CE Mark for long-term heart pump implant | Regulatory Roundup
Teleflex touts world’s 1st antithrombogenic PIC catheter | Regulatory Roundup
Cook launches peripheral drug-eluting stent in Australia | Regulatory Roundup
Medgenics wins FDA OK for Epodure trial | Regulatory Roundup
Boston Scientific’s Innova peripheral stent débuts in Europe | Regulatory Roundup
Boston Scientific (NYSE:BSX) said it plans to get its Innova stent for peripheral artery disease on the market in the European Union "immediately" now that it’s won CE Mark approval there.