FDA lets Connect-One participants use Connexus with their own personal computing devices

Paradromics/Connexus BCI

The FDA approved a change that lets participants in Paradromics' Connect-One study use the Connexus brain implant with their own compatible laptops, tablets and phones through its Convey software. New devices can be added by following an agreed testing process instead of seeking a separate FDA approval for each one. It moves the system toward something people can use wherever they are, not only on company-supplied hardware.

• Connexus decodes neural signals into intended actions; Convey turns that output into text, speech and computer control on the connected device.
• Connect-One is an early feasibility study testing safety and the ability to restore communication and computer control in people with severe paralysis.
• CEO Matt Angle: the BCI "should adapt to lives and mobility needs of users, rather than define them."