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Neuralink Competitor Synchron Receives FDA's Green Light for Human Trials

This paves the way for the first commercially available implantable brain-computer interfaces.

The future where we can get futuristic devices implanted into our brains on a whim to help treat conditions is edging closer.

Synchron, a brain data transfer company that makes implantable brain-computer interfaces (BCI), has received the Food and Drug Administration's (FDA) green light to run a clinical trial with human patients, beating out competitors such as Elon Musk's Neuralink, according to a press release by the company.

The goal is to implant a device called Stentrode™ in the brain to allow paralyzed patients to operate digital devices like computer cursors with their thoughts. To make this possible, Stentrode, which is smaller than a matchstick, communicates with a second implant in the chest through a tiny cable. The signals are then sent to a computer outside the body, near the patient, through a transmitter.

What's great and interesting about Stentrode is that, unlike many other implanted brain-computer interfaces, it doesn't require brain surgery. Instead, it is inserted into a blood vessel at the base of the neck and guided to a vessel in the brain in a minimally invasive procedure that is done in two hours, "similar to the insertion of stents in the heart."

Synchron plans to begin clinical trials with six patients at Mount Sinai Hospital, New York. This process is similar to a phase II clinical trial for a drug. The device's "safety and efficacy in patients with severe paralysis" will be evaluated in the trial, according to the firm. The trial is crucial to demonstrate that the implants are safe and might one day be commercialized in the United States.

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Synchron has already conducted a number of experiments, such as the four-patient study in Australia. Two of the patients were able to control their computer with their thoughts thanks to "data transfer from motor cortex to digital devices," according to data published in the Journal of NeuroInterventional Surgery in October 2020. Patients performed work-related tasks, texted and emailed, and used the internet for online commerce and shopping. The SWITCH clinical study is still taking place in Australia today.

According to Dr. J Mocco, the chief medical officer at Synchron and a professor of neurosurgery at Mount Sinai Health System in New York., the gadget might be available in three to five years, per Bloomberg. If the trials see success, Synchron might advance to the next stage of the years-long regulatory procedure and perhaps become the first commercially available implantable brain-computer interface.

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