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The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Read More
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