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Terminal/Device DB/Connexus Direct Data Interface
intracorticalIDEinvestigational

Connexus Direct Data Interface

Implant Type
intracortical
Electrodes
1,684
Channels
1,684
FDA Status
IDE
Clinical Stage
Connect-One Early Feasibility Study (FDA IDE approved Nov 2025)
Status
investigational
About

Paradromics' Connexus DDI is the first BCI to receive FDA IDE approval specifically for speech restoration with a fully implantable system. Each Cortical Module contains 421 microwire electrodes (~1.55mm long, <40 microns diameter) with platinum-iridium tips, and up to four modules can be deployed for 1,684 total intracortical channels. The system features on-chip low-noise amplifiers and digitizers with edge processing to minimize line noise. Data transmits wirelessly via a secure infrared link at 100 Mbit/s from the subclavicular Internal Transceiver to a wearable External Transceiver. Preclinical testing demonstrated >200 bps bit rate with 56ms system latency. The system is powered continuously via inductive coupling.

Target Conditions
ALSlocked-in syndromespinal cord injuryspeech restoration
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
2025-11FDA IDE approval for Connect-One Early Feasibility Study (speech restoration)
2026-01Enrolling at University of Michigan, MGH, and UC Davis
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