Elon Musk Neuralink Rival Cleared by FDA to Test Brain Chip in Humans
(Observer) – In April, Elon Musk’s neurotech startup Neuralink proudly demonstrated an experiment of a macaque monkey with two “Link” devices implanted in his brain playing a video game—solely with his mind. The next step, Musk said, would be testing the device in humans. While that timeline is up in the air, some of Neuralink’s quiet competitors are already making rapid progress.
Synchron, a New York startup that makes a brain-computer interface, or BCI, similar to Neuralink’s, said Wednesday it had received the FDA’s permission to test its brain device in human patients in what’s known as an early feasibility study.
Synchron’s implantable device, called Stentrode, is smaller than a matchstick. Unlike Neuralink’s “Link” device that requires drilling a two-millimeter hole in the patient’s skull to install, Stentrode is small enough to be implanted via a blood vessel at the base of the neck. The device will then be maneuvered toward a vessel in the brain.
Stentrode works by communicating through a tiny wire with a second implant in the chest. A transmitter then sends signals to an external computer near the patient.
“We have worked together to pave a pathway forward, towards the first commercial approval for a permanently implanted BCI for the treatment of paralysis,” Synchron CEO Thomas Oxley said in a statement Wednesday.
The company plans to enroll six patients in its U.S. trial later this year. An FDA-approved product could be on the market in as soon as three to five years.
Last year, Synchron carried out a four-patient trial in Australia. The U.S. study will take a closer look at safety issues, including physical risks and cybersecurity, Oxley says.
Brain-computer interface is latest frontier of artificial intelligence and biology. While the technology is in very early stage, a growing number of companies are looking to put it to commercial use, creating a challenge for the FDA.
In April, the FDA authorized the first device falling under its BCI category—a robotic wearable called IpsiHand developed by Washington University startup Neurolutions. The wearable is designed to help people disabled by a stroke regain control over their arm and hand function using their thoughts.