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Neuralink says FDA has OK’d a human trial

Neuralink says its brain-computer interface is fully implantable, cosmetically invisible, and designed to let a person control a computer or mobile device anywhere they go. [Image courtesy of Neuralink]Elon Musk’s Neuralink says the FDA has approved a first-in-human clinical trial for its brain-computer interface technology.

Neuralink said on Twitter yesterday:

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!

This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people.

Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!”

FDA media relations could not be immediately reached for comment.

Citing anonymous current and former employees, Reuters has reported that the FDA previously rejec…

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…

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…

DeviceTalkers assemble for the final Newsmakers of 2022

In this episode, your diligent team of DeviceTalkers assembled to review our Top 10 events, trends and newsmakers of 2022.

Executive Editor Chris Newmarker, Pharma Editor Brian Buntz, Managing Editor Jim Hammerand, Senior Editor Danielle Kirsh and Associate Editor Sean Whooley joined me, DeviceTalks Editorial Director Tom Salemi, for the latest DeviceTalks podcast.

We’ve got some highs — robots, diabetes — and some lows — supply chain, recalls — and a whole lot of interesting things in between. All-in-all, we’re bullish on what’s to come in 2023! And we only mentioned COVID-19 once.

Companies mentioned in our wide-ranging discussion include Abbott, Abiomed, Ambu, Becton Dickinson, Boston Scientific, CMR Surgical, Dexcom, embecta, Intuitive, Johnson & Johnson Medtech, Medtronic, Neuralink, Philips, Senseonics, Stryker, Synchron, Vicarious Surgical, Zimmer Biomet, ZimVie and many more.

You can listen to other DeviceTalks Podcast Network shows at…

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…

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…

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…

Pushing the boundaries of brain-computer interface software

[Image from Milad Fakurian on Unsplash]

Neuroscientist Sumner Norman and AE Studio develop open-source and free tools for the brain-computer interface (BCI) space.

BCI technology has become one of the hottest areas of medtech. Companies are developing a multitude of methods with their own systems that would allow patients to control a computer with their brain. Such technology could enable immobile people to control a mouse cursor, keyboard, mobile device/tablet, wheelchair or prosthetic device by only thinking.

“My goal is to give abilities back to those that have lost them, and eventually, to improve how all of us interact with technology and each other — the ultimate human-machine interface,” Norman told Medical Design & Outsourcing. “And what’s more human than our brain, the organ that contains our every memory, thought and intention?”

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 …

Report: Elon Musk looks to invest in brain-computer interface competitor Synchron

[Image from Synchron]Reuters is reporting that Elon Musk has approached his Neuralink company’s rival, Synchron, over a potential investment.

Musk’s Neuralink recently fell behind Synchron in the brain-computer interface (BCI) space after the latter announced that it completed the first-in-human brain-computer interface (BCI) implant in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery.

Synchron’s Stentrode is implanted within the major cortex through the jugular vein in a minimally invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent using a proprietary digital language to allow severely paralyzed patients to control personal devices with hands-free point-and-click.

Neuralink is working to develop an implant placed in the brain through a robot-assisted procedure. While Musk and company officials said they planned to file for FDA approval for human trials …

Synchron completes first U.S. human implant of brain-computer interface rivaling Elon Musk’s Neuralink

[Image from Synchron]Synchron announced today that it completed the first-in-human brain-computer interface (BCI) implant in the U.S.

The procedure, performed at Mount Sinai West in New York, represents the first such implant to occur in the U.S. using an endovascular BCI approach, which does not require invasive open-brain surgery.

Dr. Shahram Majidi, assistant professor of neurosurgery, neurology and radiology at the Icahn School of Medicine at Mount Sinai, led the procedure, which was performed in the angiography suite with a minimally invasive, endovascular approach. Earlier this year, Synchron’s neuroscience chief explained how this type of catheter delivery could enable better brain implants.

It was the first patient implant in Synchron’s Command trial, operating under FDA investigational device exemption to assess a permanently implanted BCI. Command will assess the safety and efficacy of the company’s motor BCI technology, includin…

Synchron says study shows safety of its brain-computer interface implant

Synchron’s Stentrode device expands inside a blood vessel on the brain to relay motor signals. [Illustration courtesy of Synchron]Four ALS patients with a Synchron Stentrode brain implant had no serious adverse events one year after their procedure, which allowed the paralyzed patients to control a computer for online shopping, banking and text communication without using their hands or voice for input.

New York-based Synchron said this study demonstrated the safety of its brain-computer interface (BCI) technology. The device is delivered by catheter rather than the open-brain surgeries used by other neurotech developers like Elon Musk’s Neuralink.

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