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Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Read More
Health Canada pointed to the last paragraph in the Food and Drugs Act’s definition of a medical device as a significant 2014 addition intended to help distinguish between products. Read More
The diagnostic agent has “the potential to benefit many patients as well as restore the U.S. ability to domestically supply a critical medical diagnostic tool for… Read More