Monitoring Desk
WASHINGTON: The US Food and Drug Administration has cleared Abbott Laboratories’ blood test for concussions. The approval would help doctors assess traumatic brain injury (TBI), generally known as concussions, the company said on Tuesday.
According to the company, the clearance marks the first commercially available laboratory blood test for traumatic brain injury, helping doctors to rule out the requirement for a CT scan in patients with mild TBI.
TBIs are caused by blow or whiplash to the head and can pose the risk of short- and long-term effects, including memory and movement impairment.
Abbott already has a plasma test for TBI and was cleared by the FDA in 2021.
The new test measures two indicators in the blood that, in elevated concentrations, are tightly correlated to brain injury, the company said.
Abbott announces launch of TEER system
Abbott also announced a first-of-its-kind minimally invasive device late-breaking data for the TriClip transcatheter edge-to-edge repair (TEER) system. The device is designed particularly for tricuspid heart valve repair.
The TRILUMINATE Pivotal study analyzed the superiority of TriClip to medical therapy in treating patients with severe, symptomatic tricuspid regurgitation (TR) at greater or intermediate risk for open-heart surgery.
