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First Concussion Blood Test Leverages De Novo, Breakthrough Pathways

Executive Summary

The Banyan Brain Trauma Indicator is the first blood test for detecting concussions in adults to reach the US market and the second device to emerge from US FDA's Breakthrough Devices Program. While test-maker Banyan Biomarkers originally flirted with the PMA pathway, FDA swayed it to the de novo process, which the firm ultimately leveraged to gain the market go-ahead.

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