STAT+: FDA approves Paradromics’ brain-computer interface trial for speech restoration

Paradromics announced Thursday that the Food and Drug Administration approved a clinical study to evaluate whether the company’s brain-computer interface for speech restoration is safe and capable of providing the ability to communicate via text or synthesized speech to someone with paralysis. 

The Austin-based company is one of a handful of startups — including Elon Musk’s Neuralink, Synchron, and Precision Neuroscience, among others — that have transformed brain-computer interfaces from an obscure academic niche to a promising neurotechnology that Morgan Stanley recently valued at $400 billion. 

The FDA nod is the latest step forward for Paradromics, which has received multiple breakthrough device designations but is racing to catch up to Synchron and Neuralink. Their clinical trials already have regulatory approval, though Paradromics CEO and co-founder Matt Angle is not shy about criticizing the competitors’ devices, including a lengthy October blog post titled, “Neuralink device limitation.”

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