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Title: Brain Implant Cleared by America's FDA to Help Paralysis Patients

Link: https://hardware.slashdot.org/story/25/04/19/...

An anonymous reader shared this report from CNBC: Neurotech startup Precision
Neuroscience on Thursday announced that a core component of its brain implant
system has been approved by the U.S. Food and Drug Administration, a major
win for the four-year-old company... The company's brain-computer interface
will initially be used to help patients with severe paralysis restore
functions such as speech and movement, according to its website. Only part of
Precision's system was approved by the FDA on Thursday, but it marks the
first full regulatory clearance granted to a company developing a wireless
BCI, Precision said in a release. Other prominent startups in the space
include Elon Musk's Neuralink, and Synchron, which is backed by Amazon
founder Jeff Bezos and Microsoft co-founder Bill Gates.... The piece of
Precision's system that the FDA approved is called the Layer 7 Cortical
Interface. The microelectrode array is thinner than a human hair and
resembles a piece of yellow scotch tape. Each array is made up of 1,024
electrodes that can record, monitor and stimulate electrical activity on the
brain's surface. When it is placed on the brain, Precision says it can
conform to the surface without damaging any tissue. The FDA authorized Layer
7 to be implanted in patients for up to 30 days, and Precision will be able
to market the technology for use in clinical settings. This means surgeons
will be able to use the array during procedures to map brain signals, for
instance. It is not Precision's end goal for the technology, but it will help
the company generate revenue in the near term. Precision's co-founder and
chief science officer also helped co-found Musk's Neuralink in 2017 before
departing the following year, according to the article. He nows says this
regulatory clearance "will exponentially increase our access to diverse, high-
quality data, which will help us to build BCI systems that work more
effectively."

Read more of this story at Slashdot.

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