Today FDA qualified the Osirix CDE Software Module biomarker test for use by medical device developers to identify and enroll patients into Traumatic Brain Injury (TBI) studies. This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a software module biomarker test tool type. A biomarker test is a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment (biomarker). Read more at https://www.fda.gov/NewsEvents/Newsroom/FDAInBrief/ucm633239.htm
Read our posting on the FDA guidance on medical device development tool (MDDT) qualification: FDA Medical Device Development Tool (MDDT) Qualification
