Research & Development
Abbott's i-STAT TBI cartridge receives US FDA approval
2 April 2024 -

Abbott, a global healthcare company, announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for its i-STAT TBI (traumatic brain injury) cartridge.

The company says that the cartridge is intended to be utilised with whole blood, enabling doctors to evaluate patients with suspected concussion at the patient's bedside and receive 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.

The new approval will allow testing to be conducted in an array of new healthcare settings beyond hospital emergency departments including urgent care clinics with a certificate to perform moderate complexity tests. The company says that 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.

With this clearance, the i-STAT TBI test can be used to help evaluate patients up to 24 hours after injury, an important advancement since those injured often wait before seeking care.