Wednesday 20 July 2022

FDA-Approved Brain Computer Interface Company “Synchron” Implants First Brain Device in US Patient

 Australia-based Synchron, the startup behind an FDA ‘breakthrough neuroprosthesis device,’ successfully implanted its first brain device in a patient in the US earlier this month, Bloomberg first reported.

According to the news outlet, a doctor at Mount Sinai West Medical Center in New York inserted a “1.5-inch-long implant consisting of wires and electrodes into a blood vessel in the brain of an ALS patient” on July 6.

In August 2020, Synchron becomes the first brain-computer interface (BCI) company to receive the FDA’s approval to conduct an investigational device exemption (IDE) clinical trial of a permanently implanted device.

NIH awarded Synchron $10 million to begin a US trial of a brain implant that allows users to manage digital apps using only their thoughts, as reported by Fierce Biotech.

“Our neuroprosthetics are designed to help people get their lives back by restoring lost functions,” Synchron wrote on its website.

According to its website, the product is called™ – “a motor neuroprosthesis designed to bypass damaged neural pathways in patients with severe paralysis, allowing them to restore motor capabilities including control of digital devices.”

Below is an illustration of how this new product works:

The procedure consists of the following steps:

  1. The stentrode™ is an endovascular implant, placed in a vein alongside the motor cortex which generates any signal related to movement.
  2. A receiver device implanted in the chest transmits the neural signals to a decoder.
  3. A machine learning algorithm translates those signals into specific digital commands.

According to Bloomberg:

The purpose of the device is to allow the patient to communicate — even after they have lost the ability to move — by using their thoughts to send emails and texts. Bloomberg reported that Synchron has already implanted the device in four patients in Australia who have been able to use the brain implant to send messages on WhatsApp and shop online.

Last year, the startup received permission from the US Food and Drug Administration (FDA) to begin human trials on six US patients who have been severly paralyzed. In 2019, the company implanted its device into its first human patient in Melbourne, Australia.

Meanwhile, Elon Musk’s flagship product, Neuralink, has not received approval from the FDA yet.

Musk said the product “will enable someone with paralysis to use a smartphone with their mind faster than someone using thumbs”.

On Monday, Elon Musk responded to a tweet and claimed he had already “uploaded his brain to the cloud.”

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