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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’s Supercharger Diner probably just secured more locations

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Credit: Tesla

Tesla’s Supercharger Diner in Los Angeles dominated the company’s global usage rankings after just one year, proving the concept is more than just a one-off novelty location that will fade away.

The performance could incite the company to build more locations, something that CEO Elon Musk has hinted at for some time.

Tesla’s Supercharger Diner delivered 21.2 GWh of energy in its first year of operation, the company’s head of Charging, Max de Zegher, revealed on X. Of the top 10 most utilized Supercharger locations in Tesla’s global infrastructure, the Diner in Los Angeles was the most used by drivers, and it wasn’t particularly close:

On its launch day one year ago, nobody was too sure what the Tesla Diner would be about. It seemed like an interesting concept, and considering it had been in the works for years, it was a highly anticipated launch that many were looking forward to.

Based on its success, we could see additional Diners with Superchargers built throughout the United States, and potentially beyond. Musk has said on several occasions that the company would be willing to bring the Diner idea to more markets.

Tesla makes major change at Supercharger Diner amid epic demand

Of the markets that Musk has mentioned, both Palo Alto and Austin have come to be perceived as ideal selections. However, there are no concrete plans as of now to build new Supercharger Diners anywhere; the location on Santa Monica Boulevard will remain the exclusive spot to pick up Tesla-inspired eats, at least for the time being.

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Investor's Corner

Tesla short sellers win big after shares fall after earnings

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A red Tesla Roadster driving around a turn
(Credit: Tesla)

Tesla short sellers won big following the company’s massive fall on Wall Street after it reported subpar Earnings on Wednesday.

Tesla short sellers collected about $4.12 billion in single-day profits on Thursday, according to BloombergShares fell as much as 15 percent during Thursday’s session. It closed as one of the worst days for Tesla on Wall Street in the past three years.

Investors sold off the stock after Tesla said it would aggressively direct its spending toward AI and its Optimus robot project. The company had record revenues, which were driven by one of the strongest quarters in terms of vehicle deliveries in company history.

However, it missed EPS estimates by reporting just $0.33, a far cry from the $0.53 analysts expected.

S3 Partners reported that about 3 percent of Tesla’s outstanding stock is sold short. Managing Director at S3, Ihor Dusaniwsky, provided the short seller’s potential profit, as well as another figure: shorts have likely had paper gains of $8.92 billion this year, as Tesla shares are down 30 percent in 2026.

Tesla (TSLA) Q2 2026 earnings results: miss on EPS, beat on revenue

Tesla has burned short sellers many times in the past, but the company’s latest Earnings Call was a chance for those skeptics to taste some payback. Although the company gave some very transparent information regarding future projects, the rollout of Robotaxi, Optimus, and Semi, many investors took their profits on Thursday.

Notable short sellers like Michael Burry have been transparent about their skepticism around Tesla shares. Burry just revealed three weeks ago that he had opened up a new short on the stock, stating he shorted Tesla shares at $416.22. “Happy it jumped back to this level,” he said in a blog post.

At the time of publication, Tesla shares were down about 3 percent and the stock was trading at $309.92.

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Tesla door handle saga gets its latest chapter and a big change is coming

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Credit: Tesla | Model 3 Owner's Manual

Tesla’s long-standing saga regarding its door handles and a manual release has entered its latest chapter, and as a result, a big change is coming.

On Friday, the National Highway Traffic Safety Administration (NHTSA) denied Tesla’s petition that was seeking a defect investigation into roughly 180,000 Model 3 vehicles for an issue involving the emergency mechanical door release.

NHTSA said that Tesla’s petition did not present evidence of a safety-related defect in the door handles or their emergency releases. Instead, the agency determined that it would rather solve the issue of the lack of labeling or location of emergency mechanical door releases and the federal safety rules that govern them.

Essentially, the NHTSA wants to create and enforce rules that would require automakers to make emergency door latch releases more clearly labeled in a car. Despite a Tesla having manual door releases on all four passenger doors, many people do not know they exist or how they work.

Tesla addresses door handle complaints with simple engineering fix

In recent times, Tesla has faced some criticism involving its door handles, specifically because some occupants have reported that they are unable to exit their vehicles after losing power. The door handles on a Tesla are electronically operated, but in the event that the 12V battery dies, there is a manual release that can be used.

The NHTSA only identified a single complaint involving the mechanical door releases: a 2022 Model 3 owner said the release was concealed and unlabeled after the vehicle lost power after a front-end collision. It has also already started to create a separate rulemaking process to make emergency door-egress systems more obvious.

It should be noted that all Teslas have mechanical emergency door releases, but they are placed in various locations as the vehicles have aged and been redesigned from year to year. Refer to the safety manual for your vehicle if you have any confusion about where the emergency releases are and how they work.

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