A peer-reviewed study published in Neuromodulation evaluated escalating transcranial focused ultrasound doses delivered to the right amygdala using the BrainSonix BX Pulsar 1002. Ten healthy volunteers received four randomized stimulation conditions ranging from 0.72 to 10.08 W/cm² ISPTA.3—up to 14 times the FDA diagnostic-ultrasound output limit.
Across all tested conditions, investigators reported no adverse events or subjective discomfort and found no MRI-detectable edema, hemorrhage, or other structural abnormalities. The highest-intensity protocols were also well tolerated.
These results provide preliminary human evidence supporting the safety of the BX Pulsar 1002 within the specific higher-intensity parameters tested. Because this was a small, safety-focused study in healthy volunteers, the findings do not establish that every protocol above diagnostic limits is safe.
