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.
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 ↗