Factbox-Neuralink, other brain-chip makers face long road to FDA approval

By Marisa Taylor

(Reuters) – Neuralink, founded in 2016, has yet to receive FDA approval to test its brain chip in humans. Other implant makers have spent years or decades on research to secure U.S. regulatory approvals.


Synchron, like Neuralink, aims to help patients with severe paralysis control digital devices. It received U.S. approval for human testing in July 2021, five years after applying to the U.S. Food and Drug Administration (FDA). The company first tested its device on four patients in Australia who successfully sent text messages with their minds – no typing required. Synchron recently raised $75 million, including from funds backed by tech billionaires Bill Gates and Jeff Bezos. As of late February, Synchron had implanted two patients with the device out of a total of six planned for its first U.S. trial.


Medtronic is a leader among several companies producing deep-brain stimulation (DBS) devices. The FDA first approved Medtronic’s implant, to treat Parkinson’s disease, in 1997. Since then, more than 175,000 patients have been implanted with the device. The device reduces Parkinson’s tremors and lessens other motor-control symptoms such as stiffness and slowness.


NeuroPace, founded in 1997, didn’t secure FDA approval for its brain implant to treat epilepsy until 2013. The device is used by adult patients who have tried at least two medications but still suffer from frequent and disabling seizures, according to the company. The device lessens the frequency of such episodes.


Blackrock Neurotech, established in 2008, has tested its brain implant in humans for almost two decades. It says the device has been shown to enable people with paralysis to control digital devices, prosthetics, and their own limbs. The company had hoped to secure approval to commercialize the implant from the FDA by last year but is still working on it, according to the company.


Precision Neuroscience, founded in 2021, includes as its co-founder former Neuralink founding member Benjamin Rapoport. The company bills its brain implant as “minimally invasive.” The implant, shaped like a piece of tape, is designed to conform to the surface of the brain. Unlike some other implants, its wires and electrodes do not need to pierce brain tissue, the company says. Like Neuralink, the company has not yet secured approval for clinical trials.

(Reporting by Marisa Taylor; additional reporting by Rachael Levy)