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/Connexus Direct Data Interface
intracorticalIDEr&d

Connexus Direct Data Interface

Implant Type
intracortical
Electrodes
196
Channels
196
FDA Status
IDE
Clinical Stage
Pre-IND / IDE preparation
Status
r&d
About

Paradromics is developing the Connexus Direct Data Interface, a high-bandwidth intracortical neural interface targeting individuals with ALS and other communication disabilities. The system uses a bundle of fine microwires rather than a rigid silicon array, aiming for lower tissue damage and improved biocompatibility over time. The company's architecture focuses on maximizing data throughput — their analog multiplexing approach is designed to record from hundreds of neurons simultaneously at high fidelity. Paradromics has demonstrated the system in large animal models and is preparing for first-in-human trials.

Target Conditions
ALSlocked-in syndromespinal cord injury
Milestones
2015-01Paradromics founded
2017-07DARPA Neural Engineering System Design (NESD) award
2020-06$20M seed raised; large animal demonstrations completed
2022-01FDA pre-submission meeting completed
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