# FDA Clears Paradromics IDE for Connect-One BCI Speech Restoration Trial

> fda · REPORTED · 2026-08-05

Paradromics received FDA Investigational Device Exemption clearance to begin the Connect-One study of its Connexus fully implantable brain-computer interface, described as the first IDE granted for a fully implantable BCI intended to restore speech for people with severe motor impairment. The company claims data throughput more than 20 times faster than intracortical systems such as Neuralink's N1 device.

About Paradromics: Paradromics is an Austin, Texas-based BCI company developing the Connexus fully implantable neural interface system for speech restoration in patients with severe motor impairment.

- Company: Paradromics
- Sector: neurotech
- Primary source: https://pharmaphorum.com/news/neuralink-rival-paradromics-cleared-start-speech-trial

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Source: MedFuel Intel news monitor. Verification tier: REPORTED. Informational only, not investment advice. Corrections: media@medfuelinc.com.