For as long as our firm has represented survivors of traumatic brain injury, we've faced the same uphill battle: how do you prove an injury that doesn't show up on a CT scan? Clients who suffer from crushing headaches, memory lapses, difficulty concentrating, and personality changes after a car crash or fall often look "fine" to a jury. Their MRIs may come back normal. Insurance adjusters and defense experts seize on that gap between how a client feels and what conventional imaging shows, arguing there's no real, measurable injury at all.
That's why a recent development in medical technology deserves the attention of every attorney who handles brain injury litigation.
What Did the FDA Approve?
VoxNeuro, a medical technology company, recently announced that the U.S. Food and Drug Administration granted 510(k) clearance for its Cognitive Function Neuroimaging (cfNI) software. cfNI is a prescription-use, FDA-cleared platform that performs objective, data-driven analysis of electroencephalography (EEG) and event-related potentials (ERPs)—essentially, the brain's electrical responses to specific stimuli or tasks—in adults ages 18 to 70.
In plain terms: this software helps physicians measure how a patient's brain actually responds during standardized cognitive tasks, and compares those results against a large reference database built from hundreds of neurologically healthy adults, representing thousands of individual data points. The output isn't a subjective checklist or a patient's self-reported symptom score—it's a quantified, repeatable measurement of brain function that a clinician can use to support a diagnosis.
Why This Matters for TBI Litigation
Traumatic brain injury cases have always suffered from an evidentiary problem. Standard imaging like CT and MRI is excellent at detecting structural damage—bleeds, fractures, visible lesions—but it often can't detect the functional impairment that follows a concussion or mild-to-moderate TBI. Neuropsychological testing helps, but it can be criticized as subjective, coachable, or dependent on effort and motivation.
EEG/ERP-based assessment fills a different niche. It measures the brain's actual electrical activity while a patient performs cognitive tasks, capturing things like processing speed, attention, and working memory at the level of neural response—not just behavioral output. That distinction matters in a courtroom. Objective, physiologically grounded data is harder for a defense expert to wave away as exaggeration, secondary gain, or "normal" post-accident stress.
With FDA clearance now in hand, cfNI has cleared a regulatory bar that carries real weight with judges, juries, and opposing experts. A 510(k) clearance means the FDA has reviewed the device and determined it is safe and effective for its intended use. That doesn't guarantee admissibility in every jurisdiction or under every state's expert-evidence standard, but it is a meaningful credibility marker—far more persuasive than an untested or purely proprietary diagnostic tool.
How Objective Brain Function Testing May Help Traumatic Brain Injury Victims
For clients whose cognitive symptoms have been dismissed or minimized because "the MRI looked normal," this kind of objective neurophysiological testing could become an important piece of the evidentiary picture. Potential applications include:
- Corroborating subjective complaints. When a client reports brain fog, slowed thinking, or memory problems, cfNI-style data can provide an objective physiological correlate rather than relying solely on self-report.
- Countering defense narratives. Insurance defense strategies often lean on the absence of "visible" injury. Quantifiable brain-response data directly challenges that framing.
- Supporting damages calculations. Documented, measurable cognitive impairment can help substantiate claims for future medical care, lost earning capacity, and diminished quality of life.
- Strengthening expert testimony. A treating physician or retained expert who can point to FDA-cleared, standardized, repeatable data has a stronger evidentiary foundation than one relying on clinical impression alone.
Will This Evidence Be Admissible in Court?
New medical technology in litigation always comes with important caveats. FDA clearance addresses safety and effectiveness for clinical use—it does not automatically satisfy the legal standards for admissibility of expert testimony, such as Daubert or Frye, which vary by jurisdiction. As with any emerging diagnostic tool, courts will need time to evaluate its reliability, and defense counsel will undoubtedly challenge its application in the litigation context. We expect to see this tested in courtrooms over the coming months and years, and we'll be watching closely.
Still, developments like this represent meaningful progress. Every advance in objective, science-based diagnostic tools helps level the playing field for people whose injuries have too often been dismissed simply because they couldn't be seen on a scan.
When to Speak With a California Traumatic Brain Injury Attorney
At Choulos Choulos & Wyle, we stay current on emerging medical and diagnostic technology because our clients deserve advocates who understand not just the law, but the science behind their injuries. If you or a loved one is struggling with cognitive symptoms after a car accident, fall, or other traumatic event—even if prior imaging came back "normal"—we encourage you to reach out. Your injury may be invisible on a scan, but that doesn't mean it isn't real, and it doesn't mean it can't be proven.
If you or someone you love has suffered a traumatic brain injury, don't navigate it alone. Call Choulos Choulos & Wyle today at (415) 417-2093 or contact us online for a free, confidential consultation. Our experienced team will listen to your story, help you understand your legal options, and fight to make sure your injury is taken seriously—whether or not it shows up on a scan.
This blog post is for informational purposes only and does not constitute legal or medical advice. If you have questions about a specific injury or case, please contact our office for a consultation.
