FDA Allows New Test for Brain Injuries

Traumatic brain injuries (TBIs) affect millions of Americans every year. Whether from falls, blows to the head, or military engagement, a TBI is a serious health concern. Recently, the FDA qualified a biomarker tool, the OsiriX CDE Software Module. This is the first biomarker tool of its type to be qualified. With the help of this tool, more efficient devices for treating traumatic brain injuries can be developed.

Evaluation of Safety and Effectiveness

The FDA is constantly seeking ways to meet the needs of patients. There are not many options when it comes to treating traumatic brain injuries. A tool that can help with safely determining the accuracy and safety of tools or treatments in development is an important step in creating more options for detecting the severity of TBI and treatment.

Hard Facts About Traumatic Brain Injuries

A mild concussion may not seem like such a big deal. TBIs are on a continuum from mild to severe. A slip and fall on a wet surface can be life-altering if you sustain a serious enough brain injury. These types of injuries can cause seizures, personality changes, and personality disorders. They can affect motor abilities as well as cognitive function.

According to the Centers for Disease Control and Prevention (CDC), approximately 2% of the population in the United States are living with disabilities related to traumatic brain injuries. Since the year 2000, over 360,000 servicemen and women have become victims of TBI, according to the Department of Defense.

FDA Working to Meet the Need

Treatment and development of necessary tools to help patients suffering from traumatic brain injuries are sorely lacking. However, with this new tool, more treatments and tools may be able to be developed faster. Diagnostic options for determining the severity of TBIs is increasing thanks to the commitment of the FDA.

Diagnostic capabilities can be used at home and abroad. Certainly, the military would welcome accurate testing tools for servicemen and women. On the home front, such tools could be used in a variety of venues, including on sports fields for kids in school and on community teams. Professional sports teams would also benefit from the use of such tools. And, of course, hospitals and trauma centers would make good use of them.

Brain injuries can be life-altering. When they are the result of an accident caused by another’s negligence, steps can be taken to ensure that the victim’s and his or her family needs are met. Personal injury representation, including cases of TBI, is one of the many legal services offered by Tison Law Group in Tampa, FL. If you have a personal injury case, give us a call and schedule a complimentary consultation.