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.
Eucomed
EU regulators warn of “knee-jerk” reform following breast implant scare | MassDevice.com On Call
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?"
Tighter EU regulatory controls proposed following PIP controversy
By Stewart Eisenhart, Emergo Group
European Union member states should take immediate steps to tighten regulatory controls over medical devices and technologies in the wake of revelations that French breast implant manufacturer Poly Implant Prothèse Company (PIP) used non-medical-grade silicone in its products.
MassDevice.com +3 | The top 3 med-tech stories for February 9, 2012.
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
If you read nothing else today, make sure you’re still in the know with MassDevice +3.
Breast implant controversy spurs a new regulatory framework for medical devices
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.
10 arrested in 2 cases of Medicare fraud | MassDevice.com On Call
MASSDEVICE ON CALL — A federal grand jury indicted 10 individuals related to 2 schemes to defraud Medicare that cost the health care program more than $2 million in false claims for durable medical equipment.
Husband and wife Gilberto Gómez and Yolanda García-Rodríguez were accused of using 3 different companies to submit false claims, purchasing each new company as the prior was placed in pre-payment status by Medicare.
Wash. governor and 11 attorneys general defend health law | MassDevice.com On Call
MASSDEVICE ON CALL — Washington state governor Christine Gregoire joined 11 state attorney generals in voicing defense for the individual insurance mandate in President Barack Obama’s health care overhaul.
The group filed documents in support of the mandate with the U.S. Supreme Court, where challenges to the health law are expected to undergo initial arguments in March.
Each filed a separate amicus brief, Law360.com reported, including Gregoire and Massachusetts Attorney General Martha Coakley.
European med-tech industry launches 5-year strategy
European medical technology industry lobby Eucomed launched its 5-year strategy for the future of the European health care system today at the Economist Intelligence Unit’s med-tech forum.
The report, "Contract for a Healthy Future," highlights ways Western Europe can future-proof its health care systems as demand grows and budgets shrink.
European medical technology industry launches 5-year strategy and commits to value-based innovation
Brussels, 12 October 2011 – The European medical technology industry association Eucomed launched today at the MedTech Forum in Brussels its 5 year industry strategy report ‘Contract for a Healthy Future’ in which the association outlines the role industry must play in steering healthcare systems onto a sustainable path. The medical technology industry acknowledges that it needs to change and will embrace, deliver and demonstrate cost-efficiency and health outcome needs of payers and policymakers, which is the essence of value-based innovation. The industry commits to playing its part and providing medical technology innovations that ensure sustainable, accessible healthcare and healthy ageing.
Medical device trade groups ink global compliance pact
By Stewart Eisenhart, Emergo Group
Nine medical device industry associations have signed on to the Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs), a document intended to promote ethically sound interactions between the groups’ member firms and health care providers.
Eucomed to European regulators: Ease requirements for smaller medical device firms
By Stewart Eisenhart, Emergo Group
European medical device industry trade group Eucomed has issued four major recommendations to the European Commission regarding easing regulatory requirements for small and medium-sized enterprises (SMEs) in order to foster innovation.