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FDA approves sideline concussion testing instrument

The first lab-quality test “capable of detecting concussions rapidly and accessibly,” right at patients’ bedsides and, someday, on the sidelines of sporting events has been approved by the FDA, according to Abby Mackey of the PITTSBURGH POST-GAZETTE. Neurotrauma Clinical Trials Center Dir Dr. David Okonkwo and his team’s efforts resulted in the test of the instrument, known as i-STAT Alinity. Manufactured by Abbott who expects i-STAT Alinity “to be available by summer 2024 to emergency rooms and urgent care centers.” Though the use on the sidelines, where Dr. Okonkwo finds himself weekly during the fall and winter as the Steelers’ team neurosurgeon, “will have to wait.” Dr. Okonkwo said, “We have every reason to believe there is significant overlap with the injuries to athletes who sustain a concussion, but we need to do studies specifically in that patient population to confirm that use.” Dr. Okonkwo and his team “anticipate taking another step toward practicality” before truly reaching the sidelines by "removing the need for a needle-and-syringe blood draw in favor of a finger-stick test, much like a glucometer." The final hurdle to use at live sporting events will include “another level of approval, by professional sports leagues and players’ unions,” as individual teams are “unable to adopt medical diagnostics such as this” (PITTSBURGH POST-GAZETTE, 4/18).

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