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Medtech

Paradromics' Brain Implant Receives FDA Approval for Speech Restoration Trials

Summary generated with AI, editor-reviewed
Heartspace News Desk
Source: Medtech Magazine
TL;DR

Paradromics received FDA approval for clinical trials of their Connexus brain chip, designed to restore speech for individuals with severe communication disabilities. The Investigational Device Exemption allows Paradromics to begin early-stage human trials of their brain-computer interface, positioning them as a competitor with Neuralink and Synchron in the neurotechnology industry.

Key takeaways

  • Neurotechnology company Paradromics has obtained FDA approval to commence clinical trials for its Connexus brain chip, as reported by Medtech Magazine
  • The implant aims to synthetically restore speech capabilities for individuals with severe communication disabilities
  • The FDA granted Paradromics an Investigational Device Exemption (IDE), enabling the company to initiate a limited, early-stage clinical study of its brain-computer interface (BCI) system
Neurotechnology company Paradromics has obtained FDA approval to commence clinical trials for its Connexus brain chip, as reported by Medtech Magazine. The implant aims to synthetically restore speech capabilities for individuals with severe communication disabilities. The FDA granted Paradromics an Investigational Device Exemption (IDE), enabling the company to initiate a limited, early-stage clinical study of its brain-computer interface (BCI) system. This approval marks a pivotal milestone, transitioning Paradromics from preclinical development to human trials. It also positions the company as a prominent competitor in the neurotechnology field, alongside industry players such as Neuralink and Synchron.

Related Topics

ParadromicsFDAbrain implantneurotechnologyclinical trials

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