“This FDA approval clears a path for our software to work on the everyday devices people already rely on – laptops, tablets, phones – so that a brain-computer interface can fit into someone’s real life rather than confine them to a fixed setup,” Paradromics Chief Clinical Officer Bill Marks told MassDevice. “ Beyond that, it’s a sign of where the entire program is heading.”
Paradromics’ Connexus BCI platform is designed to help patients with severe motor impairment communicate. The technology uses an implantable, high-density microelectrode array to gather data from the brain and send it to a transceiver implanted in the patient’s chest. The system then transmits data through the skin to an external receiver.
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The approval expands the device’s regulatory pathway that could allow users to connect to patients’ personal, internet-connected devices, such as personal phones and laptops, rather than connecting to a company-provided computer to translate decoded neural intent.
“As we think about building BCI as a technology platform, we need to push for generalized connectivity,” Paradromics Founder and CEO Matt Angle said in a news release. “That means being able to connect with the products and technology that are already part of your life. This approval begins clearing the way toward a BCI platform that can move with the user rather than tethering him or her to a fixed computing environment.”
Austin, Texas–based Paradromics received an FDA investigational device exemption (IDE) in November 2025, in what the company said at the time was the first IDE exemption for speech restoration with a fully implantable BCI. Paradromics completed the first Connexus implantation of its Connect-One early feasibility study in June 2026.
At that time, Paradromics said its first patient was a Michigan woman with difficulty speaking due to motor neuron disease.
“She’s been an extraordinary partner in working with our team to teach the system how she intends to communicate,” Marks recently told MassDevice. “She’s trained the system on thousands of words and sentences, and in the coming weeks, we’ll move into closed-loop use, where her intended words become text or synthesized voice in real time, expanding toward free, spontaneous conversation.
“In the months ahead, we’ll enroll additional participants and keep building – safely, and for the long term – toward a system people can use independently in their daily lives, steadily restoring what disease has taken away,” he said.
