Paradromics Joins FDA TAP Accelerator for Breakthrough BCI

Image credit: Paradromics

Pioneering brain-computer interface (BCI) company, Paradromics has been accepted into the US Food and Drug Administration (FDA) accelerator program for innovative breakthrough devices.

Joining the FDA Total Product Life Cycle Advisory Program (TAP) will support the ongoing development of its Connexus Direct Data Interface, the company said.

The BCI system is comprised of up to four cortical modules on the brain which record signals from over 1,600 individual neurons, plus an internal transceiver implanted within the patient’s chest to wirelessly relay data and provide power.

Those living with amyotrophic lateral sclerosis (ALS), spinal cord injury and stroke who have lost their ability to communicate will be the first to use the device.

“We want to deliver the best possible device on the safest possible timeline, and so we appreciate access to the TAP program,” said Paradromics CEO, Matt Angle in a statement.

In a recent story with CNBC, Mr Angle said he anticipated “commercial approval to sell the product no earlier than 2029”.

Paradromics has now launched a patient registry, ahead of its first human clinical trial in 2025.

Check out the full statement from Paradromics for further details.