Synchron, a rival to Elon Musk's Neuralink, has made their own version of an "implantable brain-computer interface," and it just got the green light by the Food and Drug Administration in the US to be implanted in humans. Neuralink has not yet reached this level. The studies will begin this year on six patients with severe paralysis.
The product that is going to be tested is Stentrode, and the study will be performed at Mount Sinai Hospital in New York. According to a press release, the aim is to get the patients to control certain digital devices and to achieve improvements in functional independence. Thomas Oxley, CEO of Synchron, commented on the news.
"The approval of this IDE reflects years of safety testing performed in conjunction with FDA. We have worked together to pave a pathway forward, towards the first commercial approval for a permanently implanted BCI for the treatment of paralysis. We are thrilled to finally be launching a U.S. clinical trial this year,”.
In the press release, the company describes how Stentrode has overcome hurdles that brain-computer interfaces (BCIs) generally battle. Other chips, that are under development, demand drilling into the skull to be put to place. Stentrode, on the other hand, can be put in via the vessels. When implanted, the chip allows the patient to wirelessly control devices just by thinking about moving. For now, the company is focusing on the motor cortex, but ultimately the goal is to have a whole-brain interface.
Synchron has already before implanted chips in two patients in a previous study. According to an article, one of the patients was a 75-year-old man with paralysis in upper limbs, due to Motor Neuron Disease. 36 days after the implant, he was able to email, shop and pay bills online, not needing any mouse keyboard or touchscreen. The patients met a click accuracy of 92 - 93 percent and could write between 14 to 20 characters a minute.