“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.