EU tightening up on medical-devices, U.S. could be easing


Start-up medical-device makers have been attracted to Europe over the U.S., as the regulatory environment is more liberal in the EU.

In the latter region, for example, companies only have to show that their products are no worse than existing treatments, while in the U.S., superiority has to be proved.

"For very established treatments like heart-valve treatment, that is very difficult," says Regina Hodits of investor Wellington Partners. "The U.S. has cut itself off from certain paths of innovation with this policy."

However, things may be changing a bit, with the U.S. becoming more relaxed and the Europe becoming tighter following a breast-implant scandal. In saying that, FDA approvals tumbled 44% last year.

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