FDA qualifies first biomarker test for brain injury

FDA qualifies first biomarker test for brain injury

Source: 
BioCentury
snippet: 

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.