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Paradromius Wins FDA Approval for High-Bandwidth BCI Trial

Nov 20, 2025
A groundbreaking FDA approval for Paradromius' high-resolution brain-computer interface is making waves! The Connexus device aims to restore speech for those with severe motor disabilities, marking a major leap in neurotech. Insights into its high-bandwidth performance show impressive data transfer rates. The trial, focusing on safety and decoding accuracy, raises exciting possibilities for ALS patients. Ethical debates around access and security also emerged, making this a compelling discussion on the future of communication and technology.
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INSIGHT

High-Bandwidth BCI Could Restore Fluent Speech

  • Paradromics' Connexus aims for ultra-high-bandwidth neural recording from individual neurons to restore fluent speech.
  • High transfer rates (~200 bits/s in animals) could enable far faster communication than current assistive devices.
ADVICE

Start Small And Monitor Safety Closely

  • Stage one will start with two participants to closely monitor safety and long-term stability.
  • If safe and stable, Paradromics plans to request FDA approval to expand the trial to more patients.
INSIGHT

Reading Attempted Speech From Motor Cortex

  • Connexus decodes attempted speech by reading motor cortex signals even when vocal muscles can't move.
  • The system can convert neural intent into text and synthetic speech, potentially using prior recordings to clone a user's voice.
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