FDA In Brief > FDA In Brief: FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool

FDA In Brief > FDA In Brief: FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool





FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool

Today, the U.S. Food and Drug Administration qualified the OsiriX CDE Software Module, from the TBI Endpoints Development Initiative. This is the third qualification of a medical device development tool(MDDT) by the FDA, and the first of a 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). This qualification provides a tool for more efficient development of devices in a critical area of medicine – traumatic brain injury (TBI) treatment. 

The MDDT program enables the FDA to qualify tools that medical device developers can use in the development of...