Clinical Translation

Shanghai's science commission issued a BCI industry action plan centering on medical-grade scenarios, with a clinical timeline for invasive and semi-invasive products.

Synchron reported 12-month results from the U.S. COMMAND early feasibility study in six people with severe chronic bilateral upper-limb paralysis. All participants met the primary safety endpoint of no device-related serious adverse event causing death or permanent increased disability, and motor-intent signals were converted into digital actions throughout the study. The disclosure was not a two-year pivotal-trial report.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

Vanderbilt University Medical Center has developed a method that uses post-operative CT scans and image processing to determine the physical relationship between cochlear implant electrodes and the neural interface, allowing sub-optimally positioned electrodes to be switched off for a customized map. Cochlear implants are surgically implanted devices that restore hearing by electrically stimulating the auditory nerve, and their programming has traditionally ignored where the electrodes actually sit. The trial tested whether this individualized image-guided programming improves hearing and speech outcomes in pediatric recipients, with hearing measures collected at baseline, 12 months and 24 months; it has been completed, but results have not been posted.