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FDA qualifies first biomarker test for brain injury

March 13, 2019 6:38 PM UTC

FDA said Tuesday it has qualified a biomarker test tool for use in clinical development of medical devices to treat traumatic brain injury. Developed by the University of California San Francisco’s TBI Endpoints Development Initiative, the OsiriX CDE software module is qualified for use in identifying patients for enrollment in clinical device trials to improve outcomes in patients with mild TBI.

OsiriX CDE provides a standardized tool to mark and classify brain contusions using common criteria and to label abnormalities in MRI scans...