Tighter EU medical approval will hamper US companies
US MEDICAL-device manufacturers are looking anxiously across the Atlantic as the European Union prepares to tighten the process to approve new products, a step companies say will crimp their lifeline to funding and patients.
The EU's overhaul is meant to close loopholes that allowed breast implants made with industrial-grade silicone to be implanted in thousands of women. Yet device makers say the new rules will delay approvals without increasing safety. The European Parliament is scheduled to vote on new regulations over the next couple of weeks.
Smaller US companies depend on the EU's easier process to test their products and accumulate patient data that they can use to get approval in the States.
"If the rest of the world begins to raise the bar of approval to the US level, it will surely damage investment in innovation and patient progress will plateau" said Kevin Sidow, chief executive officer of a Moximed, California-based company with a knee-implant system approved in Europe.