Seeking Alpha

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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