Abbott announces FDA clearance of i-STAT TBI cartridge

Abbott’s i-STAT TBI cartridge has received clearance from the U.S. FDA to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient’s bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing. This new clearance will enable testing to be performed in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. This is an important step toward a future where testing could be done outside traditional healthcare settings, such as on the sidelines of sporting events.