FDA Classifies Banyan Biomarkers’ Brain Trauma Assays as Class II Devices (RAPS.org)

The US Food and Drug Administration (FDA) classified brain trauma assessment tests and endoscopic electrosurgical clip cutting systems as class II devices.

Both device classifications were established via the De Novo pathway based on FDA’s review of 2016 and 2017 requests from Ovesco Endoscopy AG and UF startup Banyan Biomarkers, respectively. These in turn allow for a device sponsor of a brain trauma assay or an endoscopic electrosurgical clip cutting system to use the 510(k) pathway.

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