The FDA's Center for Devices and Radiological Health has qualified the OsiriX CDE Software Module under the Medical Device Development Tools program. The biomarker test, from the Traumatic Brain Injury Endpoints Development Initiative, is the third MDDT to obtain the qualification and is designed to facilitate brain contusion marking and classification using common data element criteria.
Brain contusion biomarker test becomes 3rd CDRH-qualified MDDT
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