Casey offers bill to streamline medical-device approvals

U.S. Sens. Bob Casey and John McCain have introduced legislation aimed at streamlining the approval process for medical devices.

Under the current system, if a company invents a medical device, it must prove to the FDA that there is nothing else like it on the market before continuing with the approval process.

The proposed legislation would do away with that requirement.

“In our case, it would have cut roughly a year off the review time. That, particularly for a small company, that is absolutely huge,” said Bruce Shook, president of Neuronetics, a Malvern-based company that sells a medical device for treating depression.

Many medical device companies win approval in Europe prior to the U.S. because the process there is faster, a trend Shook says is accelerating even more.

This legislation “is definitely something that is critical in order to keep the innovation engine of the medical device industry in the U.S., and not to move it to Europe or to Asia,” said Baruch Ben Dor, head of InfraScan, a Philadelphia medical-device company.

Casey said the bill will make it easier for Pennsylvania businesses to bring their products to market as it creates jobs.

According to estimates from 2007, medical-device companies employ more than 45,000 workers in Pennsylvania, New Jersey and Delaware.

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