The European Assn. for Medical Devices of Notified Bodies says that the number of new CE Mark certificates have dropped significantly in recent years.
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.
Here's a look at some of the top regulatory stories for medical device companies this week.
Ulthera, which makes an ultrasound device designed to lift lax tissue on the neck and under the chin...
Dr. George Bakris, co-principal investigator in Medtronic's Symplicity-3 trial, says renal...
Delivering Medical Extrusions in 3-5 days - Fast & Flexible
A federal appeals court stays a ban on U.S. sales of Medtronic's CoreValve replacement heart valve...