Do You Know Your de novo?

In July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. The act makes major changes in the way certain medical devices are considered during pre-market review. The complex law made changes to the de novo reclassification...

2013 Medtech Scorecard

The healthcare industry is big and getting bigger, worth nearly $2 trillion in 2012. The medtech industry generated $110 billion in the United States and $44 billion in exports. But even as U.S. companies lead the world in research, innovation, and manufacturing,...