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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 plans for new 300+ stall Supercharger with a special surprise for Semi

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(Credit: Tesla Owners East Bay/Twitter)

Tesla is planning for a new 300+ stall Supercharger station that will be an expansion of an existing facility, and the company is planning to add a surprise for the Semi.

The Firebaugh, California Supercharger is currently 72 Superchargers, but Tesla filed for an expansion that will add 232 additional plugs for passenger vehicles, and it also plans to add 16 Semichargers.

This will be the biggest Supercharger station Tesla will have to date, just months after it finished the Supercharger Oasis in Lost Hills, California, which has 168 stalls. This will have 304 total Supercharger stalls, and then the additional 16 Megachargers.

The Firebaugh Supercharger is located on I-5, which is a major reason for why Tesla has chosen the location for additional Megacharger plug-ins, as Tesla Semi Program Manager Dan Priestley said on X earlier today.

The project was revealed by MarcoRP, a Supercharger tracker.

The expansion is a massive signal for charging demand, especially as Tesla’s Superchargers are opened to numerous automakers and are no longer exclusive to the company’s EVs. Additionally, the installation of Megachargers is a good sign to come for the Tesla Semi program, which aims to truly ramp up this year.

Tesla plans to launch production of the Semi later this year.

It could also mean Tesla is going to expand its footprint of large-scale Supercharger projects in the coming years, which would be a big boost as EV adoption continues to soar in the United States.

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Tesla makes two big interior changes to several Model Y vehicles

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Credit: Tesla

Tesla has made two big interior changes to several Model Y vehicles in its lineup, and the changes come just as the new model year begins production.

Last year, Tesla launched the Model Y Standard, which separated the previous models into the “Premium” category. The Standard vehicles lack several features, including more premium interior materials, acoustic-lined glass, and storage.

@teslarati There are some BIG differences between the Tesla Model Y Standard and Tesla Model Y Premium #tesla #teslamodely ♬ Sia – Xeptemper

The Model Y “Premium” trims are now getting several new upgrades, which come after the company launched a seven-seat configuration of the vehicle last night in the North American market for an upcharge of $2,500.

The new Model Y seven-seat configuration did not come with just an additional row of seating; it also came with a slew of other goodies that now come standard and were previously only available on the Model Y Performance, which was launched late last year.

All Black Headliner

The new Tesla Model Y Premium trims will now come standard with a black headliner, something that many owners have been requesting for some time.

The previous grey headliner and trim within the vehicle is now gone; it will be all black on all of the Premium trims from here on out, a welcome change:

Credit: Tesla

Larger and Higher Resolution Center Touchscreen

The center touchscreen in the new Model Y Premium configuration is now larger and has a higher resolution than the previous version.

In last year’s Model Y configurations (apart from the Performance), the center touchscreen was 15.4″. Now, Tesla has decided to go with the 16″ version across all Premium trims, which is a nice step up. It was nice to see this in the Performance, but it is really great to see Tesla include this in the Model Y’s more Premium trim levels.

Tesla Model Y Seven Seater

Tesla launched the latest iteration of the seven-seater for the Model Y on Monday night. Traditionally, the Model Y seats five passengers in total, but there were calls for a more spacious version several years ago.

Tesla released it, but it was extremely tight in the back, basically reserving those back seats for only small people or children.

Credit: Tesla

The new configuration looks to be slightly more spacious in the third row, but not as much space as most would require or want. Instead,

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Lufthansa Group to equip Starlink on its 850-aircraft fleet

Under the collaboration, Lufthansa Group will install Starlink technology on both its existing fleet and all newly delivered aircraft, as noted by the group in a press release.

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Credit: Lufthansa

Lufthansa Group has announced a partnership with Starlink that will bring high-speed internet connectivity to every aircraft across all its carriers. 

This means that aircraft across the group’s brands, from Lufthansa, SWISS, and Austrian Airlines to Brussels Airlines, would be able to enjoy high-speed internet access using the industry-leading satellite internet solution.

Starlink in-flight internet

Under the collaboration, Lufthansa Group will install Starlink technology on both its existing fleet and all newly delivered aircraft, as noted by the group in a press release

Starlink’s low-Earth orbit satellites are expected to provide significantly higher bandwidth and lower latency than traditional in-flight Wi-Fi, which should enable streaming, online work, and other data-intensive applications for passengers during flights.

Starlink-powered internet is expected to be available on the first commercial flights as early as the second half of 2026. The rollout will continue through the decade, with the entire Lufthansa Group fleet scheduled to be fully equipped with Starlink by 2029. Once complete, no other European airline group will operate more Starlink-connected aircraft.

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Free high-speed access

As part of the initiative, Lufthansa Group will offer the new high-speed internet free of charge to all status customers and Travel ID users, regardless of cabin class. Chief Commercial Officer Dieter Vranckx shared his expectations for the program.

“In our anniversary year, in which we are celebrating Lufthansa’s 100th birthday, we have decided to introduce a new high-speed internet solution from Starlink for all our airlines. The Lufthansa Group is taking the next step and setting an essential milestone for the premium travel experience of our customers. 

“Connectivity on board plays an important role today, and with Starlink, we are not only investing in the best product on the market, but also in the satisfaction of our passengers,” Vranckx said. 

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