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FDA Approves First Blood Test for Brain Bleeds After Mild TBI/Concussion

The US Food and Drug Administration
(FDA) approved a blood
test in February for two biomarkers
associated with bleeding after
traumatic brain injury (TBI); the test is
intended to identify patients who do not
need to undergo imaging for intracranial
If performed within 12 hours of
injury, the test is almost 100 percent
accurate, the FDA said in its February
14 announcement. The assay was
approved in less than six months under
the FDA Breakthrough Devices Program,
in part to help prevent…..

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