A new approach to treating post-traumatic stress disorder (PTSD) has received FDA clearance, offering a personalized alternative for people who have not found sufficient relief through existing treatments. Developed by California-based Wave Neuroscience in collaboration with researchers at the Texas A&M Health Institute of Biosciences and Technology, the technology uses brain activity measurements to guide targeted magnetic stimulation. Early clinical trial findings have been encouraging: according to Wave Neuroscience, patients experienced a 52% reduction in PTSD symptoms, while 68% achieved remission. 
The full findings are still being prepared for public release, but researchers believe the technology could significantly expand treatment options for millions of people. The need for more effective PTSD care is substantial—in the United States, approximately 17.5 veterans die by suicide each day, and about 7% of veterans receive a PTSD diagnosis annually—while an estimated 6% of Americans will experience PTSD during their lifetime, with higher rates among women and veterans. 
Since PTSD was formally recognized as a diagnosis in 1980, treatment has largely centered on psychotherapy and medications known as selective serotonin reuptake inhibitors (SSRIs), including sertraline and fluoxetine; although these approaches can help, many patients continue to experience symptoms despite receiving treatment. 
A 2020 review of PTSD medications found that patients reported improvements ranging from 6.8 to 10.1 points on symptom assessments, yet remission rates reached only 10.9% at most, which makes Wave Neuroscience's substantially stronger preliminary outcomes stand out. 
Erik Won, DO, the company's chief medical officer, described the results as a major advance over previously reported medication outcomes. “In comparison to that study, our FDA trial reported a 52% reduction in symptoms, so more than a four-fold increase in efficacy,” Won said. “And more importantly, we saw 68% remission in our clinical trial. So, it’s really a quantum change, an inflection point in what we can offer to patients. From a clinical care perspective, that’s really meaningful.” 
These findings are promising, although the results come from different studies and should not be interpreted as a direct comparison of treatment effectiveness. The newly cleared system uses Magnetic e-Resonance Therapy (MeRT), a technology that combines measurements of brain activity with targeted magnetic stimulation: first, an electroencephalogram (EEG) records the brain's electrical signals, and this information helps guide a personalized treatment plan using transcranial magnetic stimulation, or TMS, in which a coil positioned against the scalp delivers magnetic pulses that stimulate brain activity—a technique already used for other psychiatric conditions, including treatment-resistant depression. 
What distinguishes MeRT is its use of an AI-assisted algorithm to customize stimulation protocols based on each patient's brain activity rather than relying on a standardized approach. “Transcranial magnetic stimulation, or TMS, was previously FDA cleared for treatment-resistant depression,” Won said. “By adding an augmented AI derived multivariate algorithm, we were able to personalize protocols that received FDA clearance for post-traumatic stress disorder, which should open up market access to about 13 million people who may be struggling with PTSD.” 
Dr. Kenneth S. Ramos, a physician-scientist at Texas A&M Health with extensive experience in precision medicine, helped guide the research, focusing on adapting medical care to the characteristics of individual patients instead of assuming that everyone will respond to the same treatment. “Most clinical interventions for the treatment of PTSD do not work very well,” Ramos said. 
“So, this is a huge area where identifying interventions that could hopefully add quality of life to the people impacted by this disorder would be tremendously impactful.” Wave Neuroscience CEO Fred Walke said Ramos was a natural fit for the project because of his expertise in personalized medicine. Conventional TMS generally follows treatment protocols that are less individualized, whereas MeRT builds on the same underlying technology but adjusts treatment according to the patient's specific brain activity.  Ramos emphasized that even small biological differences between people can have major implications for medical care—humans are approximately 99.9% genetically alike, yet the remaining 0.1% contributes to differences that can influence how individuals respond to treatment and by accounting for these differences and tailoring stimulation to each person's brain, researchers observed substantial reductions in PTSD symptom severity. 
Ramos illustrated the distinction with an analogy involving a leaking roof, likening conventional TMS to covering a leak with a tarp to manage its effects, while MeRT aims to provide a more targeted solution, comparable to identifying and replacing the damaged shingles responsible for the problem, with the broader goal of moving beyond standardized protocols toward interventions guided by measurable biological information. 
The regulatory process reached an important milestone in 2024, when MeRT received an FDA Breakthrough Device designation, which Dr. Rick Silva, executive director of clinical trials at the Texas A&M Health Institute of Biosciences and Technology, explained helps promising technologies move through regulatory review more efficiently without eliminating scientific or medical requirements, instead streamlining communication and reducing administrative delays while preserving the standards needed for FDA clearance. Silva said the progress was particularly meaningful because the project began during the COVID-19 pandemic and advanced through the regulatory process unusually quickly, according to Silva, medical device development and clinical evaluation can often take around 10 years before clearance is obtained, but this project completed the relevant process in just over two years, a pace he credited to the experience and dedication of the Wave Neuroscience team.