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.
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 ↗