Here's an excerpt of an interesting article from Bloomberg. May or may not have an impact on OSL but keen for those in the know to cast their eyes over it... :)
Medical-Device Makers See EU Rules Slowing U.S. Approvals
U.S. 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. The draft, once approved, will be the basis for negotiating with member states on final rules.
Smaller U.S. 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 U.S., the world’s most profitable health-care market. They can get their devices approved in Europe years earlier than in the U.S., according to the European device-industry group Eucomed.
OSL Price at posting:
13.5¢ Sentiment: Hold Disclosure: Held
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