Neurotech company Paradromics has received approval from the US Food and Drug Administration (FDA) to broaden the range of personal computing devices compatible with its investigational brain-computer interface (BCI) system.
The authorisation pertains to the company’s ongoing Connect-One Early Feasibility Study, which is evaluating the safety and functionality of the Connexus BCI for restoring communication and enabling computer-device control in individuals with severe motor impairment.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The FDA approval will enable the BCI platform to support a wider variety of internet-connected personal devices including laptops, tablets and mobile phones.
Paradromics intends to implement these changes through its Convey user interface, which is designed to translate decoded neural signals into communication and digital control across supported platforms.
Previously, the BCI system was limited to use with company-provided hardware.
The approval marks what Paradromics describes as a step towards allowing users with severe motor impairment to interact with the types of devices they use in everyday life.
Once Paradromics completes the agreed deployment and testing process, new compatible personal devices could be added without requiring separate approvals for each device.
The company stated that this change does not affect the existing clinical care model in the study but offers greater flexibility to assess how BCI-enabled computer control might fit into individual daily digital environments.
Paradromics founder and CEO Matt Angle said: “As we think about building BCI as a technology platform, we need to push for generalised connectivity.
“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.”
Paradromics is developing its BCI platform to decode neural activity recorded at the level of single neurons, with initial studies focused on restoring communication for people unable to speak due to paralysis and severe motor impairments.
The company’s stated long-term strategy aims to enable the translation of neural intent into actions across an expanding range of technologies and applications.
In March this year, Paradromics initiated a programme to drive academia’s access to its BCI to advance innovation in the device space.
