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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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Man credits Grok AI with saving his life after ER missed near-ruptured appendix

The AI flagged some of the man’s symptoms and urged him to return to the ER immediately and demand a CT scan.

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Credit: Grok Imagine

A 49-year-old man has stated that xAI’s Grok ended up saving his life when the large language model identified a near-ruptured appendix that his first ER visit dismissed as acid reflux. 

After being sent home from the ER, the man asked Grok to analyze his symptoms. The AI flagged some of the man’s symptoms and urged him to return immediately and demand a CT scan. The scan confirmed that something far worse than acid reflux was indeed going on.

Grok spotted what a doctor missed

In a post on Reddit, u/Tykjen noted that for 24 hours straight, he had a constant “razor-blade-level” abdominal pain that forced him into a fetal position. He had no fever or visible signs. He went to the ER, where a doctor pressed his soft belly, prescribed acid blockers, and sent him home. 

The acid blockers didn’t work, and the man’s pain remained intense. He then decided to open a year-long chat he had with Grok and listed every detail that he was experiencing. The AI responded quickly. “Grok immediately flagged perforated ulcer or atypical appendicitis, told me the exact red-flag pattern I was describing, and basically said “go back right now and ask for a CT,” the man wrote in his post. 

He copied Grok’s reasoning, returned to the ER, and insisted on the scan. The CT scan ultimately showed an inflamed appendix on the verge of rupture. Six hours later, the appendix was out. The man said the pain has completely vanished, and he woke up laughing under anesthesia. He was discharged the next day.

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How a late-night conversation with Grok got me to demand the CT scan that saved my life from a ruptured appendix (December 2025)
byu/Tykjen ingrok

AI doctors could very well be welcomed

In the replies to his Reddit post, u/Tykjen further explained that he specifically avoided telling doctors that Grok, an AI, suggested he get a CT scan. “I did not tell them on the second visit that Grok recommended the CT scan. I had to lie. I told them my sister who’s a nurse told me to ask for the scan,” the man wrote. 

One commenter noted that the use of AI in medicine will likely be welcomed, stating that “If AI could take doctors’ jobs one day, I will be happy. Doctors just don’t care anymore. It’s all a paycheck.” The Redditor replied with, “Sadly yes. That is what it felt like after the first visit. And the following night could have been my last.”

Elon Musk has been very optimistic about the potential of robots like Tesla Optimus in the medical field. Provided that they are able to achieve human-level articulation in their hands, and Tesla is able to bring down their cost through mass manufacturing, the era of AI-powered medical care could very well be closer than expected. 

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Tesla expands Model 3 lineup in Europe with most affordable variant yet

The Model 3 Standard still delivers more than 300 miles of range, potentially making it an attractive option for budget-conscious buyers.

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Credit: Tesla

Tesla has introduced a lower-priced Model 3 variant in Europe, expanding the lineup just two months after the vehicle’s U.S. debut. The Model 3 Standard still delivers more than 300 miles (480 km) of range, potentially making it an attractive option for budget-conscious buyers.

Tesla’s pricing strategy

The Model 3 Standard arrives as Tesla contends with declining registrations in several countries across Europe, where sales have not fully offset shifting consumer preferences. Many buyers have turned to options such as Volkswagen’s ID.3 and BYD’s Atto 3, both of which have benefited from aggressive pricing.

By removing select premium finishes and features, Tesla positioned the new Model 3 Standard as an “ultra-low cost of ownership” option of its all-electric sedan. Pricing comes in at €37,970 in Germany, NOK 330,056 in Norway, and SEK 449,990 in Sweden, depending on market. This places the Model 3 Standard well below the “premium” Model 3 trim, which starts at €45,970 in Germany. 

Deliveries for the Standard model are expected to begin in the first quarter of 2026, giving Tesla an entry-level foothold in a segment that’s increasingly defined by sub-€40,000 offerings.

Tesla’s affordable vehicle push

The low-cost Model 3 follows October’s launch of a similarly positioned Model Y variant, signaling a broader shift in Tesla’s product strategy. While CEO Elon Musk has moved the company toward AI-driven initiatives such as robotaxis and humanoid robots, lower-priced vehicles remain necessary to support the company’s revenue in the near term.

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Reports have indicated that Tesla previously abandoned plans for an all-new $25,000 EV, with the company opting to create cheaper versions of existing platforms instead. Analysts have flagged possible cannibalization of higher-margin models, but the move aims to counter an influx of aggressively priced entrants from China and Europe, many of which sell below $30,000. With the new Model 3 Standard, Tesla is reinforcing its volume strategy in Europe’s increasingly competitive EV landscape.

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Tesla FSD (Supervised) stuns Germany’s biggest car magazine

FSD Supervised recognized construction zones, braked early for pedestrians, and yielded politely on narrow streets.

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Credit: Grok Imagine

Tesla’s upcoming FSD Supervised system, set for a European debut pending regulatory approval, is showing notably refined behavior in real-world testing, including construction zones, pedestrian detection, and lane changes, as per a recent demonstration ride in Berlin. 

While the system still required driver oversight, its smooth braking, steering, and decision-making illustrated how far Tesla’s driver-assistance technology has advanced ahead of a potential 2026 rollout.

FSD’s maturity in dense city driving

During the Berlin test ride with Auto Bild, Germany’s largest automotive publication, a Tesla Model 3 running FSD handled complex traffic with minimal intervention, autonomously managing braking, acceleration, steering, and overtaking up to 140 km/h. It recognized construction zones, braked early for pedestrians, and yielded politely on narrow streets. 

Only one manual override was required when the system misread a converted one-way route, an example, Tesla stated, of the continuous learning baked into its vision-based architecture.

Robin Hornig of Auto Bild summed up his experience with FSD Supervised with a glowing review of the system. As per the reporter, FSD Supervised already exceeds humans with its all-around vision. “Tesla FSD Supervised sees more than I do. It doesn’t get distracted and never gets tired. I like to think I’m a good driver, but I can’t match this system’s all-around vision. It’s at its best when both work together: my experience and the Tesla’s constant attention,” the journalist wrote. 

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Tesla FSD in Europe

FSD Supervised is still a driver-assistance system rather than autonomous driving. Still, Auto Bild noted that Tesla’s 360-degree camera suite, constant monitoring, and high computing power mark a sizable leap from earlier iterations. Already active in the U.S., China, and several other regions, the system is currently navigating Europe’s approval pipeline. Tesla has applied for an exemption in the Netherlands, aiming to launch the feature through a free software update as early as February 2026.

What Tesla demonstrated in Berlin mirrors capabilities already common in China and the U.S., where rival automakers have rolled out hands-free or city-navigation systems. Europe, however, remains behind due to a stricter certification environment, though Tesla is currently hard at work pushing for FSD Supervised’s approval in several countries in the region.

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