NLINKN1 Chip+PRIME.StudySYNCRStentrode+$75M.SeriesDPRECNLayer 7+FDA.BrkthruPARAMArgo+$20M.SeriesBBLKRKNeuroport+200.ImplantsEMTIVMN8+$45M.SeriesBKRNLFlux+Non-invasiveNRBLEHalo+Consumer.BCINEURONeuroPace+RNS.SystemCOGNICognixion+ALS.TrialFUND.YTD2026$2.8B.SectorTRIALSActive50+.ClinTrialsIMPLNTSHumans~100.Intracrtnl
Terminal/Device DB/BrainGate Neural Interface System
intracorticalIDEinvestigational

BrainGate Neural Interface System

Implant Type
intracortical
Electrodes
96
Channels
96
FDA Status
IDE
Clinical Stage
BrainGate2 long-term study (NCT00912041), active
Status
investigational
About

BrainGate is a research consortium comprising Brown University, Stanford University, Case Western Reserve University, and Massachusetts General Hospital, running the world's longest-duration human intracortical BCI study. The BrainGate2 trial uses Blackrock Utah Array electrodes implanted in motor cortex to record neural signals for communication and motor control. Key milestones include the first demonstration of a tetraplegic patient controlling a robotic arm for self-feeding, wireless BCI transmission, and high-speed typing by imagined handwriting. The program is led by Leigh Hochberg (MGH/Brown) and has enrolled more than 30 participants.

Target Conditions
ALSspinal cord injurylocked-in syndromebrainstem stroke
Milestones
2004-01First BrainGate human implant (Matthew Nagle, ALS)
2012-05Cathy Hutchinson self-feeds with robotic arm (Nature)
2021-07Wireless BrainGate demonstrated (IEEE TNSRE)
2023-09Participant achieves 62 WPM typing via imagined handwriting (Nature)
FDA Regulatory Pathway
Investigational Device Exemption (IDE)

An IDE permits a device to be used in a clinical study to collect safety and effectiveness data required for a PMA or 510(k) submission. IDE devices are not approved for commercial sale.

FDA Device Regulatory Guidance ↗
Other intracortical Devices