A study recently appeared in the NEJM comparing the average approval times for innovative, high risk medical devices in the U.S. and in Europe. It appears for new devices the approval times are similar overall. I think the key is that these are innovative (new technology) rather than more of the same. The authors of this Perspective study, “based their case on data showing that reimbursement decisions figure as prominently as regulatory ones in delaying—or expediting—patient access to innovative, high-risk devices.”

http://www.cardiovascularbusiness.com/index.php?option=com_articles&article=34754