Elon Musk may be upset: Neuralink’s rival is close to getting approval for brain implant

A not-so-subtle race is underway in the emerging brain-computer interface or BCI industry. Companies are developing an implant that can be placed in the brain to shape disease and the future. Neuralink, led by Elon Musk, failed to obtain the necessary approval from the US Food and Drug Administration (FDA) to begin human trials. But rival company Paradromics is one step closer to FDA approval for a brain implant.

Race heats up in the field of brain implants

At neurotechnology startup Paradromics, a growing team of nearly 50 employees is working on a brain implant that sounds like science fiction. Founded in 2015, Paradromics is developing a device that can help severely paralyzed patients regain their ability to communicate by decoding nerve signals. The company recently announced that it has received the “Breakthrough Device” designation from the FDA for the Connexus Direct Data Interface or CDDI system it has developed.

Paradromics is part of the emerging brain-computer interface or BCI industry. BCI can be thought of as a system that decodes brain signals and translates them into commands for external technologies. Experts believe these systems could one day help treat diseases such as blindness and mental illness. However, developing and deploying a brain-computer interface implant is no easy task. The FDA wants extensive testing and solid evidence. Because the implant inserted into the brain may unintentionally pose life-threatening risks. As of May, no BCI company has received final approval from the FDA.

Manned experiments targeted in 2024

Paradromics’ BCI device, the CDDI implant, is characterized as an auxiliary communication device that converts neural signals into text or synthesized speech. A system of tiny electrodes is implanted directly into brain tissue, where it measures and decodes brain signals and sends them to external devices via a transceiver implanted under the skin in the chest. Paradromics’ solution is designed to last 10 years and will be used primarily to assist patients who have lost the ability to communicate physically.

The company is currently conducting safety trials in animals, and data from those trials will help the FDA determine whether to approve a study in humans. Paradromics aims to begin the first clinical trials with human patients in the first half of 2024.