Cognixion wins FDA breakthrough designation for BCI for assistive communication

The Cognixion One Axon brain-computer interface (BCI) system. [Image courtesy of Cognixion]Cognixion announced today that it received FDA breakthrough device designation for its flagship brain-computer interface (BCI) technology.

Santa Barbara, California-based Cognixion designed the Cognixion One Axon as an assisted reality device. It utilizes bionic combination or AI, augmented reality and assistive technology.

The company designed the system to help people with severe motor impairments communicate and interact more effectively and independently. It utilizes electroencephalogram (EEG) technology to provide a BCI. This enables patients with advanced disease progression to communicate responses in a wearable, augmented reality headset.

By integrating AI, Cognixion aims for the device to rapidly support communication intentions and desired outcomes. It could provide suggestions capable of quick selection and audible and visual communication. The company spec…

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Elon Musk’s Neuralink reportedly seeks partner for human trials of brain implant

A screen grab from a Neuralink video of a monkey playing Pong through it’s brain-computer interface [Image courtesy of Neuralink]Neuralink, Elon Musk’s brain-computer interface (BCI) venture, reportedly aims to find a clinical trial partner for in-human studies.

Reuters reported today that six people familiar with the matter say Neuralink wants to tap the Barrow Neurological Institute as a partner. Phoenix, Arizona-based Barrow is, according to Reuters, one of the biggest neurosurgery centers in the U.S.

Neuralink’s search for a human trials partner comes on the heels of a turbulent couple of years.

During a Nov. 30, 2022 show and tell, Musk said that Neuralink would have the first in-human implant of its N1 device within the next six months. Reuters reported earlier this month that Neuralink sought FDA permission in early 2022 for human clinical trials of its BCI.

Those reports said the company received an application rejection fro…

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The FDA reportedly rejected Neuralink clinical trials a year ago

A screen grab from a Neuralink video of a monkey playing Pong through it’s brain-computer interface [Image courtesy of Neuralink]Elon Musk’s Neuralink sought FDA permission in early 2022 for human clinical trials of its brain-computer interface — and received an application rejection, Reuters reports.

The news service cited seven current and former employees. Musk and other Neuralink officials declined to talk to Reuters.

During a Nov. 30, 2022 show and tell, Musk said that Neuralink would have the first in-human implant of its N1 device within the next six months.

The N1 implant is about the size of a coin. It’s rechargeable remotely and goes along with electrode-laced threads that go further into the brain. In addition, Neuralink has an R1 robot that’s supposed to be programmed to implant the BCI system while avoiding vasculature.

Musk, in November, said the Neuralink team has been busy improving and miniaturizing the system.

Bra…

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Synchron says study backs its brain–computer interface’s safety

The Stentrode endovascular electrode array for brain-computer interface [Image courtesy of Synchron]Synchron’s stent-like brain-computer interface is getting a boost from new clinical study results out of Australia.

JAMA Neurology today published peer-reviewed, long-term safety results involving four people with severe bilateral upper-limb paralysis. Twelve months after having Synchron’s Stentrode implanted inside a blood vessel in the brain, there were no adverse events. In addition, there was no vessel occlusion or device migration.

On top of the positive safety results, the Stentrode demonstrated it could work. All four patients’ BCI implants had stable signal strength throughout, with a mean (SD) signal bandwidth of 233 (16) Hz. There was offline decoding of at least five attempted movement types. Plus, each patient learned to successfully control a computer with the BCI.

“The SWITCH study is an early demonstration of safety in a low n…

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Synchron raises $75M Series C for BCI with investments from Bill Gates, Jeff Bezos

[Image from Synchron]Synchron announced today that it raised an oversubscribed $75 million Series C financing round for its brain-computer interface (BCI) technology.

Gates Frontier (Bill Gates’ investment fund) and Bezos Expeditions (Jeff Bezos’ investment fund) participated in the round. ARCH Venture Partners led the funding. Reliance Digital Health, Greenoaks, Alumni Ventures,Moore Strategic Ventures and Project X also joined.

Existing investors participating included Khosla Ventures, NeuroTechnology Investors, METIS, Forepont Capital Partners, ID8 Investments, Shanda Group and University of Melbourne. According to a news release, the Series C brings Synchron’s total fundraising to $145 million.

“We have an opportunity to deliver a first-in-class commercial BCI. The problem of paralysis is much larger than people realize. 100 million people worldwide have upper limb impairment,” said Dr. Tom Oxley, CEO & founder, Synchron. “We are e…

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Neuralink reportedly faces probe over animal testing

A screen grab from a Neuralink video of a monkey playing Pong through it’s brain-computer interface [Image courtesy of Neuralink]Elon Musk’s brain-computer interface venture Neuralink faces a U.S. Department of Agriculture Inspector General animal welfare investigation, according to Reuters.

Reuters cited sources familiar with the investigation and company operations. The sources said the Agriculture Department opened the probe at a request of a federal prosecutor.

The Reuters report described a high-pressure environment at Neuralink in which errors resulted in the need to repeat experiments, with more animals losing their lives as a result.

Reuters said it did not receive a response back from Musk and Neuralink. However, the company has an entire webpage about its commitment to animal welfare. It mentions that the company has never received a USDA citation. The webpage says:

“In the present day, we at Neuralink are privileged to have the…

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Neuralink to implant its BCI in a person within 6 months

A screen grab from a Neuralink video of a monkey playing Pong through its brain-computer interface [Image courtesy of Neuralink]Elon Musk’s brain-computer interface venture Neuralink plans the first-in-human implant of its N1 device within the next 6 months, Musk said during a show-and-tell last night.

Neuralink officials later said the company was working with the FDA on an eventual approval and was optimistic about starting its first-in-human clinical trial.

Viewers got to see an 18-month-old video of a monkey playing Pong through the implant.

“The monkeys enjoy doing the demo, and they get the banana smoothie, and it’s a fun game,” Musk said. He added that implants had only gone into monkeys after exhaustive benchtop testing. He seemed to be trying to dispel criticism that Neuralink had caused animals to suffer.

The N1 implant is about the size of a coin. It’s rechargeable remotely and goes along with electrode-laced thread…

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Neuralink co-founder unveils Science Eye sight restoration implant

The Science Eye. [Image from Science]Neuralink co-founder Max Hodak and the Science team unveiled the Science Eye, the company’s brain-computer platform.

Now the Science CEO, Hodak helped start Neuralink, Elon Musk’s venture into brain-computer interfaces (BCIs). He served as president there until 2021. He’s now working on a new brain-computer platform. Contrary to Neuralink and other companies’ platforms, this one doesn’t require an in-skull implant.

The Science Eye is a visual prosthesis. It targets retinitis pigmentosa (RP) and dry age-related macular degeneration (AMD), two forms of serious blindness. The combination device uses an optogenetic gene therapy targeted at the cells of the optic nerve. It combines that with an implanted, flexible thin-film, ultradense microLED display panel inserted directly over the retina.

Hodak, Yifan Kong, Alan Mardinly, Corey Wolin, Emma Zhou and the Science team authored a news release unv…

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Synchron to begin enrollment at UPMC for brain-computer interface trial

The Synchron brain-computer interface system relays signals from the brain to a device in the chest, then translates the signals into action on a computer. [Image courtesy of Synchron]Synchron announced today that it started enrollment in the Command trial for its brain-computer interface (BCI) technology.

The company commenced enrollment at the University of Pittsburgh in Pittsburgh, Pennsylvania. It plans for its early feasibility study to primarily assess safety while exploring quantified efficacy measures of the Synchron Stentrode.

Synchron’s study, funded by the National Institutes of Health (NIH), involves patients with severe paralysis. It aims to enable the patient to control digital devices, hands-free.

READ: 7 brain-computer interface companies you need to know

The study operates under an FDA investigational device exemption (IDE). Synchron said in a news release that it marks the first such IDE for assessi…

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7 brain-computer interface companies you need to know

[Image from Milad Fakurian on Unsplash] Blackrock Neurotech, BrainGate, ClearPoint Neuro, Neuralink, Synchron and more race to bring brain-computer interface (BCI) tech to market.

They’re using a multitude of methods —  and developing their own systems that would allow patients to control a computer with their brain.

Such technology could potentially enable countless immobile people someday to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking.

The FDA last year issued leapfrog guidance for nonclinical testing and study design related to implanted brain-computer interface (BCI) devices. Leapfrog guidance allows the agency to share its initial thoughts on emerging technologies that are early in development but appear likely to be of importance to public health.

Companies have faced a number of challenges as they try to bring brain-computer interface technology to the market, but they continue to …

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Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how

The Synchron brain-computer interface system relays signals from the brain to a device in the chest, then translates the signals into action on a computer. [Image courtesy of Synchron] Synchron’s catheter delivery could make brain-computer interface technology simpler, safer and more accessible than the leading alternative: open-brain surgery.

Officials at Synchron — developer of the catheter-delivered Stentrode brain-computer interface (BCI) implant — believe they’re the only BCI company tapping into blood vessels to capture signals from the brain.

They say they’ve already enabled a small group of paralyzed ALS patients to control a computer with their minds, and hope there will be more technology applications.

Shortly after the New York–based company released new results of a safety study for its implant, Synchron Director of Neuroscience Peter Yoo spoke with Medical Design & Outsourcing about the Stentrode implant and how catheter deliv…

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