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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.
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.
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.
Elon Musk
Elon Musk weather update tips Tesla Roadster speculation into Plaid Mode
Tesla CEO Elon Musk certainly tipped off some details of the Tesla Roadster event with a broadening of information regarding the company’s decision to delay the unveiling for two weeks.
For years, people have speculated about what the Roadster will be capable of. While there have been plenty of things said about what it *could* do, we have not seen or been told by Tesla what it will actually be capable of.
However, over the past few days, Tesla’s weather updates have truly pushed the speculation into Plaid Mode, basically all but confirming the car will have some sort of aerial capability — whether that would be hovering or fully flying remains to be seen — but it definitely seems that it will be able to leave the ground intentionally.
“Because this event can only be held outdoors…”
Tesla posted on Monday that it would delay the Roadster event until October 15, and it indicated that it had to do this because the event “can only be held outdoors.”
With the potential SpaceX collaboration to develop cold-gas thrusters that will help the vehicle go airborne, doing this indoors is probably not a safe, or even plausible, possibility.
Roadster event update
We’ve been tracking the weather closely with local meteorologists, but given the severe conditions predicted & because this event can only be held outdoors, we’ve made the difficult decision to reschedule.
New date is October 15. Additional details to…
— Tesla (@Tesla) September 28, 2026
FAA Airspace Restriction
The FAA gave Tesla a Temporary Flight Restriction (TFR) for 10,000 feet above ground level, much higher than the typical 2,000-foot restrictions that are usually placed at SpaceX’s McGregor, Texas site.
Tesla Roadster event requires restricted airspace, and the FAA obliges
Some have said that this massive increase is due to Tesla’s need to restrict unauthorized drone use for spying on the event.
Elon Admits High Winds
“Due to high winds, the new Roadster demo is postponed by 2 weeks,” Musk said in a post on X yesterday.
Due to high winds, the new Roadster demo is postponed by 2 weeks https://t.co/dV3ojDh1iT
— Elon Musk (@elonmusk) September 30, 2026
A reply reading, “What’s strong wind got to do with a car demo with four grounded wheels?” was directly below Musk’s post, satirically and sarcastically probing for more details.
All signs are pointing toward an aerial demonstration for the Roadster.
News
Tesla snags $30B in fresh credit lines for expanding its biggest projects
Tesla has secured $30 billion in fresh credit lines from Citibank and Wells Fargo in an effort to scale its biggest current projects.
Tesla agreed to a $20 billion three-year delayed-draw term loan facility from Citibank, it announced on Tuesday. Additionally, it signed a five-year, $8 billion revolving credit facility and a $2 billion, 364-day term credit facility with Wells Fargo.
In a filing with the Securities and Exchange Commission (SEC), that it “may draw” from the $20 billion delayed-draw term “from time to time” and “no more than ten times during the 18 months following the closing date.” This loan matures on September 29, 2029.
The five-year revolving facility from Wells Fargo will also be accessed by Tesla “from time to time,” and will become due and payable on September 29, 2031. Tesla can request two separate one-year extensions.
On the $2 billion, 364-day revolving loan, it becomes due and payable on September 28, 2027. Tesla can also increase its additional commitments to an additional $4 billion across the Revolving Facilities. This would increase the total facilities to $14 billion. Tesla said it does not plan to utilize any of these loans in 2026.
Tesla plans to utilize the money to help prop up its ambitions to scale its biggest products, each of which is either in early launch phases or still in development. Of course, we’re talking about Cybercab and Semi, which have launched, and Optimus, which is still under heavy development and working toward initial release.
All three Tesla products have one thing in common: they’ve all required Tesla to build new manufacturing lines for them.
For the Semi, Tesla built a brand new factory in Sparks, Nevada, adjacent to the Tesla Gigafactory. For Optimus, Tesla sunset Model S and X production at the Fremont Factory, which brought an end to the two flagship models, thus creating manufacturing space for the humanoid robot. Finally, Cybercab is being built at Gigafactory Texas and officially entered production earlier this year.
The cash will help Tesla bolster its finances for the continuing development of these products. Tesla said that it forecasts its CapEx to be over $25 billion, up from just over $8.5 billion last year. These loans surely help with that spending.
Elon Musk
Elon Musk and Trump are closer than ever, and Tesla could be the big winner
Elon Musk sat beside Trump as AI leaders signed a voluntary White House safety accord.
Elon Musk had the seat right next to President Donald Trump on Tuesday as the White House hosted the leaders of America’s biggest artificial intelligence companies for a lunch that ended with a voluntary industry accord on AI safety.
A seating chart Trump posted on Truth Social placed Musk at the president’s left in the East Room, with Nvidia CEO Jensen Huang on his right, according to an Associated Press reporter. Anthropic CEO Dario Amodei, OpenAI President Greg Brockman, Meta’s Mark Zuckerberg, Google’s Sundar Pichai, Microsoft’s Satya Nadella and Amazon founder Jeff Bezos also attended, along with Vice President JD Vance and House Speaker Mike Johnson.
🚨 Elon Musk is currently speaking to the media alongside President Trump after a meeting with AI Leaders in Washington today
Trump says AI is now being called “Super Intelligence” or SI pic.twitter.com/woJJqUVP9B
— TESLARATI (@Teslarati) September 29, 2026
After the lunch, Trump told reporters outside the West Wing that the executives had signed “The White House Accord on Superintelligence: A Joint Commitment on Frontier SI Responsibilities.” Johnson described it as a voluntary statement of principles built on “robust internal controls and layers of internal and external review,” while Zuckerberg said company boards would independently review reports from outside auditors. Trump called the document “morally binding,” said he would name a new AI czar within days, and signed an executive order formally renaming artificial intelligence “super intelligence,” CNBC reported.
Musk was not in the room for Tesla alone. Since SpaceX absorbed xAI, he runs the company behind Grok and one of the largest AI training operations anywhere. On September 25, he said another 220,000 Nvidia GB300 chips would come online at Colossus 2 within a week, with more expected in November and December.
“I think it is worth highlighting the positive benefits of A.I. … S.I., pardon me.”
“Thank you.”@elonmusk catches his own slip after calling the technology “A.I.” while speaking alongside President Trump and other tech leaders, quickly correcting himself to “super… pic.twitter.com/fH7CFileNb
— Fox News (@FoxNews) September 29, 2026
SpaceX confirms third massive compute deal at Colossus data center
Musk also used the trip to restate his energy ambitions. “SpaceX is aiming together with Tesla to do 200 gigawatts of solar production per year,” he said at an event in Washington. It is the same combined target he laid out that feeds directly into Terafab, the Tesla and SpaceX chip venture that will need enormous amounts of power.
The showing between Musk and Trump has come a long way, since the two had the very public split in mid 2025 after Musk opposed the “Big Beautiful Bill” and left DOGE. They reconciled at Charlie Kirk’s memorial that September, and Trump later called their relationship “good”. Since then, Musk has joined Trump’s China delegation in May and attended last week’s White House state dinner for Chinese President Xi Jinping.
For Tesla, that access to government official could pay dividends. As Teslarati noted in January, federal autonomy rules, NHTSA oversight and a single national standard for driverless vehicles all run through an administration Musk can more easily reach directly as Tesla works to scale Robotaxi and Cybercab beyond Texas.