
Paradromics
Paradromics, a U.S. BCI startup, is emerging as a key neural tech contender after FDA approval for a human trial of its speech-restoration implant for people with paralysis.
The Austin-based company, with multiple FDA Breakthrough Device designations, received IDE approval for its Connexus BCI Connect-One Early Feasibility Study. It is the first company to obtain IDE clearance for a fully implantable BCI intended for speech restoration.
Assessing Connexus BCI’s Potential to Restore Communication Abilities
The study will test Connexus BCI’s safety and performance, aiming to help people with paralysis communicate via text or voice.
The company says Connexus is designed for long-term clinical use and is the first high–data-rate BCI built for top performance.
The device has a titanium-alloy casing with 400+ electrodes and onboard processing to capture brain activity. Each electrode measures under 40 microns—thinner than a human hair.
How the Fully Implantable BCI System Operates
The full BCI system implants under the skin, captures motor signals, and wirelessly transmits them via a chest transceiver to an AI-powered computer that converts them into text, speech, or device controls.
“We’re thrilled to introduce this new hardware into a clinical study,” says Matt Angle, CEO of Paradromics.
The initial trial will involve two participants receiving 7.5-mm-wide implants in the motor cortex to capture neuron activity. They will imagine speaking sentences, with signals sent to an external computer. Over time, the system will learn which neural patterns correspond to specific speech sounds, tailoring the interface to each user.
First BCI Trial Aiming for Real-Time Personalized Synthetic Speech
This marks the first BCI study focused on generating a synthesized voice in real time, using past recordings of the participants’ speech as a basis.
Researchers will also test whether the implant can pick up neural signals linked to imagined hand movements, which could enable cursor control.
If early results are promising, the trial may expand to include 10 participants, with two of them receiving dual implants for stronger signal acquisition.
“It’s an exciting step,” says Mariska Vansteensel, a BCI expert at the University Medical Center Utrecht. “A fully implantable system is essential for the technology to advance toward real-world clinical use.”
Read the original article on: New Atlas
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