Author Archives: IAMERS

EU Committee Backs Tougher, U.S.-style Device Approval System

A European Parliament committee finally voted on proposed reforms to the region’s medical device regulatory process. Industry insiders were likely apoplectic about the outcome: The group came out heavily on the side of a U.S.-style premarket approval system for high-risk devices.

Read more here.

New Study Shows Medical Device Prices Have Dropped Significantly Since 2007

Among the AdvaMed study’s conclusions: Average inflation-adjusted prices for the 7 biggest medical device categories dropped from 2007 through 2011. The trend has taken place as hospitals have increasingly turned to tighter spending controls. Medical device prices continue at less than 50% of the pace of inflation in the overall U.S. economy.

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FDA Releases Final Ruling on UDI

The U.S. Food and Drug Administration announced a final ruling today on the unique device identification system (UDI).

Read about it here.

With ‘Helium Cliff’ Dodged, More Challenging Discussions Await

On September 19th, the U.S. Senate passed an amended version of the Responsible Helium Administration and Stewardship Act, or HR 527, which was approved by the House of Representatives earlier this year. It still needs to be officially signed into law, but this is a major step to averting a helium shortage that had been looming for months.

Read about it here.

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