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Home » E.U. regulators dishing out fewer CE Marks, study finds | MassDevice.com On Call

E.U. regulators dishing out fewer CE Marks, study finds | MassDevice.com On Call

June 28, 2013 By Sony Salzman

MassDevice On Call

MASSDEVICE ON CALL — European regulators have become increasingly coy with their CE Markings, especially for new medical devices, according to a report by the European Assn. for Medical Devices of Notified Bodies, or TEAM-NB.

A survey comparing data from 2010 to 2012 showed a decrease in CE Mark certificates overall and a "significant" decrease in new CE Marks, TEAM-NB reported. The trends are consistent among Europe-based as well as non-European companies, they added.

 Low risk prostate cancer is increasingly over-treated, study says
A recent study reported that advanced treatments for prostate cancer are on the rise, even in patients that are not likely to benefit from a more aggressive procedure.

The authors pegged this trend to direct-to-consumer advertisements and fee-for-service medical payments. The uptick in advanced radiation and surgical treatments has many concerned about over-treatment of a manageable, low-risk disease.
Read more

 Mass. Senate wants exemption from certain parts of Obamacare
Governor Deval Patrick might have to ask Obama to duck out of part of healthcare reform based on a new waiver filed by the Mass. Senate. Democratic budget writer for the Commonwealth, Senator Stephen Brewer, is pushing back hard against policies he and others fear will increase insurance premiums, some by as much as 50%, for a majority of the Bay State’s small businesses.
Read more

 New laws would allow PAs, nurses to order home healthcare for Medicare
Four large nursing and home healthcare associations put their weight behind a proposal to give physician assistants and nurses more clinical decision-making power.

A bipartisan proposal in the House would allow PAs and nurses to order home healthcare for elderly Medicare patients, a measure that would be especially important in rural areas where patients have little access to primary care.
Read more

 Senate proposes "rewards" program for seniors with good health
U.S. Senators Ron Wyden (D-Ore.) and Rob Portman (R-Ohio) want to reward Medicare recipients who stay healthy, using savings expected to be generated by healthier seniors to fund the program.

The duo proposed a measure that would offer healthy seniors hundreds of dollars for meeting goals in general wellness criteria such as blood pressure, cholesterol and tobacco use, with rewards growing to $400 by the program’s 3rd year.
Read more

Filed Under: Healthcare Reform, Medicare, News Well, Oncology Tagged With: CE Mark, On Call, U.S. Congress, White House

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