BCI.INTEL
NLINKN1 Chip+PRIME.StudySYNCRStentrode+$200M.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/Cognixion ONE
EEGnonecommercial

Cognixion ONE

Implant Type
EEG
Electrodes
8
Channels
8
FDA Status
none
Status
commercial
About

The Cognixion ONE is a mixed-reality headset combining EEG-based BCI with augmented reality and an AI-powered augmentative and alternative communication (AAC) platform. Uses passive EEG electrodes to detect P300 event-related potentials and SSVEP signals as selection mechanisms, combined with eye tracking and facial expression detection. An onboard neural network trained on individual brain patterns predicts intended communication targets. Targets individuals with ALS, cerebral palsy, spinal cord injury, and other conditions affecting speech and movement.

Target Conditions
ALScerebral palsylocked-in syndromespinal cord injuryAAC needs
Milestones
2014-01Cognixion founded in Santa Barbara, CA
2021-03$12M seed round from Samsung NEXT and Intel Capital
2022-09Cognixion ONE commercial availability
FDA Regulatory Pathway
No FDA Regulatory Status

This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.

FDA Device Regulatory Guidance ↗
Other EEG Devices