Expanded device pathway advances development of the Paradromics BCI platform toward greater mobility, independence, and everyday digital access
AUSTIN, Texas--(BUSINESS WIRE)--Paradromics Inc., a leader in neurotechnology and developer of the world’s highest-data-rate brain-computer interface platform, today announced that it has received an approval letter from the U.S. Food and Drug Administration (FDA) expanding the types of computing devices that may be used with its investigational BCI system. The approval creates a pathway for Paradromics to support compatible personal, internet-connected devices through Convey™, its user-facing system for translating decoded neural intent into communication and computer control.
The expansion represents an important step beyond a company-provided computing environment and toward a BCI designed to work with the technology people use in their everyday lives. Following the agreed upon deployment and testing process, compatible personal devices such as laptops, tablets, and phones can be added without requiring Paradromics to seek approval for each new device.
“As we think about building BCI as a technology platform, we need to push for generalized connectivity,” said Matt Angle, PhD, founder and CEO of Paradromics. “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.”
Convey is designed to serve as the connection between decoded neural intent and the digital world. Paradromics’ neural decoding software processes brain signals to determine intended output, while Convey enables that output to be used for communication and computer control across supported digital devices.
The immediate value of the FDA expansion is greater flexibility and internet connectivity, but its longer-term significance is mobility. For future BCI users, personal computing could take many forms: a device mounted to a wheelchair, a laptop used for work, a tablet carried throughout the home, or a mobile device that travels with the user. Paradromics is developing its platform around the principle that the BCI should adapt to the lives and mobility needs of users, rather than define them.
Said William J. Marks Jr., MD, MS-HCM, Chief Clinical Officer of Paradromics, “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.”
Paradromics is initially evaluating its BCI platform for restoring communication and computer control in people with severe motor impairment. The company’s broader development strategy is focused on creating a high-bandwidth neural interface capable of translating human intent into action across an expanding range of technologies and applications.
The FDA-approved Connect-One Early Feasibility Study is currently evaluating the Connexus® Brain-Computer Interface, including its ability to safely restore communication and enable computer-device control. The expanded device pathway does not change the underlying clinical care model of the study; instead, it provides Paradromics with greater flexibility to evaluate how BCI-enabled computer control can eventually work within the personal digital environments of future users.
About Paradromics
Paradromics builds brain-computer interface (BCI) technologies for seamless human-technology integration, designed to restore and enhance human capabilities. The company’s first-generation device, the Connexus® BCI, is designed to capture neural activity at the resolution of individual neurons and translate neural intent into speech, computer control, movement, and other essential human functions. Paradromics’ first clinical application focuses on restoring communication for people who have lost the ability to speak due to paralysis and other severe motor impairments. Over time, the platform is designed to support direct AI interaction, advanced prosthetics, sensory feedback, and next-generation treatments for mental health and other neurological conditions. With each new application, Paradromics aims to create a new path to functional recovery where biological cures have not yet been discovered or may not be possible, expanding human capability and enabling the fuller expression of human intelligence. Paradromics is headquartered in Austin, Texas. For more information, visit www.paradromics.com.
Caution: Connexus® BCI is an investigational device. Limited by United States law to investigational use.
Connexus® and Paradromics™ are trademarks or registered trademarks of Paradromics Inc. All other trademarks are the property of their respective owners.
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