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Stark & Stark

Making the Invisible Visible: How Diffusion Tensor Imaging Sheds Light on Mild Traumatic Brain Injury

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Mild traumatic brain injury (mTBI), often called a concussion, is one of the most misunderstood injuries in medicine and law. Doctors, insurers, and defense experts frequently point to “normal” CT or MRI scans as proof that...more

Holland & Knight LLP

FDA Issues Draft Guidance on Use of "Real-World Evidence" in Medical Device Decision-Making

Holland & Knight LLP on

The U.S. Food and Drug Administration (FDA) issued on July 27, 2016, a draft guidance document addressing how it may use data and evidence collected outside of the traditional clinical trial context to support medical device...more

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