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Neuralink device gets FDA recognition for speech restoration

Neuralink device gets FDA’s ‘breakthrough’ designation. With Link, a man with ALS now types, navigates, and speaks.

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(Credit: Neuralink/YouTube)

Neuralink’s brain-computer interface (BCI) device, Link, has secured the U.S. Food and Drug Administration’s (FDA) “breakthrough” designation for restoring communication in patients with severe speech impairment. This milestone advances Elon Musk’s vision of merging human cognition with technology.

The Link device targets individuals with neurological conditions like Amyotrophic Lateral Sclerosis (ALS), stroke, spinal cord injury, cerebral palsy, and multiple sclerosis. In a recent X video, Neuralink’s third PRIME Study participant, Bradford G. Smith, who lives with ALS, showcased the device’s potential.

Using Link, Smith regained his ability to communicate, leveraging AI to narrate with a synthesized version of his former voice. “I am typing this with my brain,” Smith wrote. “It is my primary communication.”

Smith edited the X video with the help of Link. In the video, he demonstrated how Link enabled him to control a computer cursor to communicate, highlighting the BCI’s ability to interface with external devices.

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Before Link, Smith relied on an eye tracker, which limited communication in bright settings and restricted his mobility. Now, Neuralink’s implant enables him to connect more freely. His experience shows Neuralink’s progress in empowering paralyzed individuals and those with neurodegenerative diseases through revolutionary assistive solutions.

The company is also exploring applications for vision restoration and other health challenges. In 2024, Neuralink received the FDA’s ‘breakthrough device’ tag for its Blindsight device. Elon Musk explained that Blindsight would help people who have lost both eyes and function in their optic nerve to see. However, Neuralink’s current focus remains on mobility and communication.

Neuralink recently expanded its patient registry to include participants worldwide. The PRIME Study, likely the primary target for new registrants, tests Link’s base capabilities. Meanwhile, the CONVOY study explores Link’s ability to control robotic devices, like an assistive robotic arm. This broader access underscores Neuralink’s commitment to scaling its trials.

The company is reportedly preparing for a $500 million funding round, with preliminary talks valuing Neuralink at $8.5 billion pre-money and potentially $9 billion post-money, though terms remain fluid. Neuralink has not commented on the speculation about funding.

By earning FDA breakthrough status, Neuralink positions Link as a transformative tool for those with severe speech impairments. Smith’s experience illustrates its potential to restore independence, while ongoing trials and funding efforts signal the company’s ambition to redefine human-technology interaction for neurological conditions and beyond.

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Maria--aka "M"-- is an experienced writer and book editor. She's written about several topics including health, tech, and politics. As a book editor, she's worked with authors who write Sci-Fi, Romance, and Dark Fantasy. M loves hearing from TESLARATI readers. If you have any tips or article ideas, contact her at maria@teslarati.com or via X, @Writer_01001101.

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Tesla exec reveals shock development with Cybercab

“If we have to have a steering wheel, it can have a steering wheel and pedals.”

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(Credit: Teslarati)

Tesla is planning to launch the Cybercab in the second quarter of next year, and it is designed to be fully autonomous, so much so that the company is planning to build it without a steering wheel or pedals.

However, a Tesla executive said today that the company could ditch that idea altogether in what would be a major shift from the plans the company, and especially its CEO Elon Musk, have announced for the Cybercab.

Earlier today, Robyn Denholm, the company’s Chair for the Board of Directors, revealed that Tesla would potentially switch up its plans for the Cybercab based on potential regulatory requirements.

Credit: Tesla Europe & Middle East | X

Currently, even autonomous vehicles that operate for companies like Tesla and Waymo are required to have steering wheels and pedals. From a regulatory perspective, this could halt the plans Tesla has for Cybercab.

Denholm said in an interview with Bloomberg:

“If we have to have a steering wheel, it can have a steering wheel and pedals.”

Interestingly, Musk and Tesla have not veered away from the idea that the vehicle will be without these operational must-haves.

Since the vehicle was revealed last October at the We, Robot event in Los Angeles, Tesla has maintained that the car would be built without a steering wheel or pedals, and would equip two seats, which is what is statistically most popular in ride-sharing, as the vast majority of rides have only one or two passengers.

Musk doubled down on the plans for Cybercab as recently as last week, when he said:

“That’s really a vehicle that’s optimized for full autonomy. It, in fact, does not have a steering wheel or pedals and is really an enduring optimization on minimizing cost per mile for fully considered cost per mile of operation. For our other vehicles, they still have a little bit of the horse carriage thing going on where, obviously, if you’ve got steering wheels and pedals and you’re designing a car that people might want to go very direct past acceleration and tight cornering, like high-performance cars, then you’re going to design a different car than one that is optimized for a comfortable ride and doesn’t expect to go past sort of 85 or 90 miles an hour.”

Cybercab is fully conceptualized as a vehicle that has zero need for pedals or a steering wheel because it is aimed toward being fully reliant on a Level 5 autonomous platform.

Tesla is ramping its hiring for Cybercab vehicle manufacturing roles

Regulators could get in the way of this, however, and although the car could drive itself and be a great solution for ride-hailing, it might need to have these controls to hit the road in the future.

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SpaceX opens up free Starlink service for those impacted by Hurricane Melissa

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(Credit: Starlink | X)

SpaceX is opening up its internet service, Starlink, to those impacted by Hurricane Melissa, as it made landfall in Jamaica and the Bahamas as a Category 5 storm.

Hurricane Melissa is expected to reach wind speeds of over 165 MPH over the next few days as it extends out into the Atlantic Ocean by Thursday and Friday.

Citizens in Jamaica and the Bahamas have been preparing for the storm for the past week, getting necessary goods together and preparing for the massive storm to arrive. It finally did yesterday, and the first images and video of the storm are showing that it could destroy many parts of both countries.

Starlink is now being opened up for free until the end of November for those impacted by the storm in Jamaica and the Bahamas, SpaceX announced today:

It is a move similar to the one the company made last year as Hurricane Helene made its way through the United States, destroying homes and property across the East Coast. SpaceX offered free service for those impacted by the destruction caused by the storm.

The free Starlink service was available until the end of 2024.

Elon Musk’s companies have also made similar moves to help out those who are impacted by natural disasters. Tesla has offered Free Supercharging in the past, most notably during the California wildfires.

Tesla and SpaceX’s LA fire relief efforts: Cybertrucks, free Starlink and more

One major advantage of Starlink is that it is available for use in situations like this one, where power might be required to operate things like a modem and router.

Internet access is a crucial part of survival in these situations, especially as it can be the last leg some stand on to get in touch with emergency services or loved ones.

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Tesla board chair reiterates widely unmentioned point of Musk comp plan

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Credit: Tesla

Tesla Board Chair Robyn Denholm appeared on Bloomberg TV this morning to discuss the current status of CEO Elon Musk’s compensation plan, and used the opportunity to reiterate a widely unmentioned key point of the entire package.

Critics of the proposed pay package, which would pay Musk $1 trillion if he completes every tranche, routinely cite the sheer size of the payday.

Of course, many skeptics leave out the fact that he would only get that money if he were able to generate eight times the value the company currently has.

Tesla gains massive vote of confidence on compensation plan for Elon Musk

For Musk, it might have a little bit to do with money, but that is likely a very small percentage point of why the compensation package is being offered to him. He has reiterated that it is more about voting control and overall influence, especially as Tesla dives into robotics.

He said during the Q3 Earnings Call:

“My fundamental concern with regard to how much voting control I have at Tesla is if I go ahead and build this enormous robot army, can I just be ousted at some point in the future? That’s my biggest concern. That is really the only thing I’m trying to address with this. It’s called compensation, but it’s not like I’m going to go spend the money. It’s just, if we build this robot army, do I have at least a strong influence over that robot army, not current control, but a strong influence? That’s what it comes down to in a nutshell. I don’t feel comfortable wielding that robot army if I don’t have at least a strong influence.”

Tesla shares the idea that Musk is a crucial part of the company, and without him being awarded the voting control he feels he deserves, he could leave the company altogether.

The company is very obviously feeling the importance of the upcoming vote, as it has advertised and pushed heavily for the comp plan to be approved, mostly to retain Musk.

Tesla Board Chair Robyn Denholm said today to Bloomberg TV that it is crucial shareholders understand it is not about Musk’s potential wealth, but more about his influence on company decisions:

“So firstly, it is a performance package, so he gets nothing if he doesn’t perform against the pretty audacious milestones that are part of the performance criteria that’s been outlined by the board in the performance package. So, I think rather than compensation, it’s actually about the performance and the goals that we have for the company as we move forward. And so, for me, it really is about making sure that investors understand that they actually get paid if he hits the milestones before he will…Elon’s been very public, including on last week’s earnings call, about the fact that it’s around the voting influence that he could have in future shareholder meetings as opposed to the economic interests.”

Musk is not an incredibly flashy person. He does not have crazy cars or a massive house to go back to. He spends a lot of his time working and sometimes even sleeps at his office inside the factory.

He recently said he “only has what is needed” because “material possessions were making him weak.”

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