Traumatic Brain Injury - TBI for early detection for concussions.
The U.S. Department of Defense also collaborated on the project. In September 2016, the U.S. Food and Drug Administration gave the green light to BrainScope to begin marketing the Ahead 300. Early detection Grant from the NFL.
BrainScope worked with the Purdue Neurotrauma Group to conduct a study in collegiate athletes using imaging biomarkers such as functional MRI (fMRI) and Diffuse Tensor Imaging (DTI) to potentially enhance BrainScope's urgent care, handheld EEG-based traumatic brain injury detection technology. This study could provide a demonstration that the BrainScope system can function as a surrogate for these imaging biomarkers and as a field-based diagnostic for traumatic brain injury (TBI). This could potentially provide a more robust assessment of injury and recovery and lead to more objective return-to-play decisions. BrainScope devices under development are for investigational use only.
BrainScope One® -- Patient Advantages
Cleared by the FDA.
Patient-friendly. It’s easy to use (patients simply wear a headset), non-invasive (no radiation!), and does not require a visit to the ER or hospital.
Accurate and comprehensive. BrainScope One® is the only device that objectively assesses the entire spectrum of injury – including concussions. It has demonstrated 99 percent sensitivity in detecting a brain injury that would be visible on a CT scan.
Fast. An assessment can be completed in less than 20 (Check with BSO #)
Convenient. It involves shorter wait times, lower costs and less stress than a typical ER visit or outpatient CT scan. You can get an immediate answer about the severity of your head injury, as well as the needed follow-up treatment, all from one provider with BrainWaves Concussion Care.
Easy to Use
It’s a medical tool that has the potential to greatly assist frontline care of head injuries.
“With mild TBI as prevalent as it is,” says Geoffrey Ling, MD, COL, USA (Ret.) in a September 26, 2016, BrainScope release, “an objective easy-to-use point of care device to identify those patients at highest risk of concussion is a critical need.”
“With over five million U.S. patients seen each year with closed head injuries, and millions more who do not seek evaluation, the Ahead 300 allows for head-injured patients to be objectively assessed at the point of care, including locations of intercollegiate and professional sports, thereby significantly improving triage, medical management, and the ultimate clinical diagnosis.
The ability to rapidly identify TBI can meaningfully reduce the morbidity and mortality of head-injured patients.” Backed in part by Steve Case's Revolution, BrainScope is a medical neurotechnology company creating hand-held instruments to help rapidly assess traumatic brain injury. The company received an award from GE and the NFL.
Steven Case, the former chairman of AOL, has been an investor in BrainScope for more than seven years. He brought the company from St. Louis to Bethesda around 2008 and has served on its board. His wife, Jean, now serves on the BrainScope board.
BrainScope expects The Ahead 300 to be commercially available in the coming months.
Neurovascular coupling dysfunction is the cause of many post-concussion symptoms. Unfortunately, this type of damage won’t show up on a standard magnetic resonance imaging (MRI), so if your doctor is trying to connect your symptoms to a brain injury, standard imaging won’t show anything wrong.
FX uses functional
Neurocognitive Imaging (fNCI), a
special type of MRI to detect neurovascular coupling dysfunction.
Hope with Treatment
EPIC Treatment includes two fNCI scans, a neck and brain MRI, and a week of intensive therapy specific to each patient’s brain injury and symptoms. This makes our methodology effective and unique.