Medtronic offers EU concessions in $43 billion Covidien deal
European Commission
Medtronic reveals leadership team after mega-merger with Covidien | The week in medtech M&A
EuroZone anti-trust regulators to rule next month on $43B Covidien buy
Medical device makers find new layer of regulation before earning CE Mark approval | Regulatory news for the week of August 4, 2014
Medical device makers face new obstacles to European approval
Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.
The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.
European regulators issue guidance on nanotechnology in medical devices
By Stewart Eisenhart, Emergo Group
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
FDA wants another advisory panel hearing for BSX Watchman anti-stroke device | Regulatory news for the week of June 23, 2014
Scotland curbs use of transvaginal mesh amid global outcry
Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.
