Boston Scientific lands expanded FDA indication for biliary stone removal with CRE dilator
Regulatory Roundup
Nevro wins FDA approval to launch spinal stimulation trial | 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.
St. Jude lands FDA wins for CRM devices reducing unneeded shocks | Regulatory Roundup
Boston Scientific wins FDA nod for latest pacemaker set
Boston Scientific (NYSE:BSX) said the FDA approved the latest set of its pacemakers, including a device designed to treat patients who can’t regulate their heartbeats while exercising.
The Natick, Mass.-based med-tech maker said the watchdog agency granted pre-market approval for its Ingenio and Advantio pacemakers and for its Invive cardiac resynchronization therapy pacer.
FDA clears Ethicon’s 1st surgical set docs can assemble inside the body | Regulatory Roundup
Johnson & Johnson (NYSE:JNJ) Ethicon Endo-Surgery won FDA clearance for the 1st surgical instruments that can be assembled and disassembled inside the body during surgery.