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FDA Approves First Rapid Handheld Concussion Test

The new blood test can help diagnose mild traumatic brain injuries in just 15 minutes.

Each year, roughly five million Americans are examined in the emergency room for suspected mild traumatic brain injuries. According to a recent Medscape article, a new rapid blood test could cut down on wait times and reduce unnecessary CT scans by up to 40%. The device is the i-STAT Alinity TBI plasma test manufactured by Abbott Laboratories, and it was developed in collaboration with the US Department of Defense. The handheld device is the first rapid blood test for concussions to receive FDA approval.

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
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Medical Device Innovations Report
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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FDA warning letters surge - is your team prepared?