Non-invasive BCI

The FDA cleared Forest Devices' SignalNED System (Model RE) on September 3, 2025, finding it substantially equivalent under submission number K251726 through the traditional 510(k) pathway. The agency classifies it as a Reduced-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Forest Devices has applied reduced-montage EEG to prehospital stroke identification, acquiring interpretable signals in settings such as ambulances.

Neuracle Medical Technology (Shanghai) Co., Ltd. ran a clinical trial in China evaluating the safety and efficacy of its implantable wireless brain-computer interface, NEO, in patients with tetraplegia caused by spinal cord injury. The trial is registered on ClinicalTrials.gov as NCT06990412 and is listed as completed; its stated primary purpose was to provide the basis for product registration. NEO is designed to let patients control external devices with brain signals.

Austrian company g.tec medical engineering GmbH has registered a brain-computer interface rehabilitation trial in Parkinson's disease on ClinicalTrials.gov as NCT06690931, first posted on November 15, 2024 and marked completed as of the entry's September 3, 2026 update. It evaluates recoveriX PRO, which pairs motor imagination with functional electrical stimulation (FES) and virtual reality feedback, the user wearing an EEG cap whose recorded neural activity drives the feedback devices, and it asks whether the therapy significantly improves motor function, whether it outperforms standard treatment, and whether it is equally safe. The BCI group trains six times a week for four weeks, 24 sessions in all, while the control group gets the same schedule of FES and VR without EEG monitoring; no results are posted in the registry entry.

The University of Texas at Austin has registered a study on ClinicalTrials.gov, NCT05907343, testing whether non-invasive stimulation can strengthen cognitive control in older adults, enrolling both people with cognitive impairment and people without it. It asks whether theta burst stimulation, a form of transcranial magnetic stimulation, can restore a range of cognitive functions, and whether delivering it in closed loop, timed to ongoing brain activity rather than on a fixed schedule, changes the result.