The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Health care giant Johnson & Johnson (NYSE:JNJ) submitted concessions to the European Commission reviewing the company’s $21.3 billion buyout of Synthes Inc. in hopes of easing regulator concerns.
The Eurozone regulators extended the deadline for a decision on the proposed merger until April 26, to grant additional time to review the concessions, the details of which were not made public.
MASSDEVICE ON CALL — British medical regulatory Kent Woods warned against reactionary reforms to the European device review process amid growing clamor for overhaul in light of the public health crisis surrounding substandard breast implants.
"The question that arises is whether the broad principle of how we do it in Europe is right or not?" Woods told a press briefing in London. "Are we looking for incremental improvements to a system that is in place, or are we looking for root and branch change?"
European med-tech lobby Eucomed joined forces with regulators in calling for a revised framework for medical device review in light of the ongoing public health crisis surrounding substandard breast implants.
The European Commission called for immediate action to tighten controls and increase surveillance following the discovery of "fraudulent use of non medical grade silicone in breast implants" manufactured by a French device company, Poly Implant Prothese.
