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.
The first blood test that can detect concussions in adults is headed for the US market following a regulatory process that took advantage of key FDA streamlining trends.
FDA and Banyan Biomarkers Inc. announced the marketing authorization of the Banyan Brain Trauma Indicator Feb. 14. The test checks a patient's blood for proteins that move from the...