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The FDA said the Banyan Brain Trauma Indicator has the potential “to rule out the need for a CT scan in at least one-third patients who are suspected of having mTBI.” Read More
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