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www.fdanews.com/articles/213493-abbott-gets-clearance-for-15-minute-traumatic-brain-injury-test

Abbott Gets Clearance for 15-Minute Traumatic Brain Injury Test

April 5, 2024

Abbott announced on Monday that its hand-held, rapid blood test for assessing patients with suspected concussion got FDA clearance to be used with whole blood, allowing doctors to test for mild traumatic brain injury in healthcare settings outside hospital emergency departments.

Previously, the tests to help with the assessment of possible concussions were only cleared for use with plasma or serum, requiring samples be sent to a lab for processing.

Called the i-STAT TBI cartridge, the test measures two biomarkers from the brain that may be released into the bloodstream, indicating a possible brain injury.

Read Abbott’s announcement here.

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