Paradromics Gets FDA OK to Expand BCI Access to Personal Devices

Paradromics has received U.S. Food and Drug Administration (FDA) approval expanding the types of computing devices that can be used with its investigational brain-computer interface (BCI) system.

The approval allows Paradromics’ Convey system to support compatible internet-connected personal devices, including laptops, tablets, and smartphones, for communication and computer control. The pathway enables users to add compatible devices through an established deployment and testing process without requiring separate approval for each device.

Convey connects Paradromics’ neural decoding software with supported digital devices, translating decoded neural intent into communication and computer control. The FDA expansion adds internet connectivity and greater device flexibility, allowing the BCI to support personal computing across laptops, tablets, smartphones, and other compatible devices.

Paradromics is initially evaluating its BCI platform to restore communication and computer control for people with severe motor impairment. The FDA-approved Connect-One early feasibility study is assessing the safety and performance of the Connexus BCI for these applications. The expanded device pathway does not alter the study’s clinical care model but provides greater flexibility to evaluate BCI-enabled control across users’ personal digital environments.

Earlier this year, the company launched a new Application Expansion (APEX) Partnership Program to initiate collaborative working relationships between the company and academic researchers advancing BCI science.

Comments from Paradromics execs

Matt Angle, Ph.D., founder and CEO: “As we think about building BCI as a technology platform, we need to push for generalized 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.”

William J. Marks Jr., MD, MS-HCM, chief clinical officer: “We live much of our lives online, and access to a personal device can mean the ability to work, communicate with family, manage daily activities and participate more fully in the world. Designing for that experience is an important part of translating BCI technology from a clinical research system into something that can ultimately support people in everyday life.”