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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.”

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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.

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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.

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 ingenious improvement to one of its best features

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Credit: Tesla

Tesla is planning to improve one of the best features on its lineup of cars, a new patent shows. Tesla’s massive glass roof on its premium models is among the coolest additions to the all-electric vehicles, but the design certainly has its complaints, especially from those who live in even slightly warm climates.

Tesla has published a new patent that promises to transform cabin comfort in its electric vehicles, particularly those equipped with the expansive glass roofs.

The document, identified as US20260091643A1 and titled “Airflow Optimization for Cabin Comfort“, addresses that common complaint. Sunlight streaming through windshields and panoramic roofs creates localized hot air pockets near the dashboard and headliner. These pockets generate significant temperature gradients that conventional heating, ventilation, and air conditioning systems struggle to manage evenly.

The exposure to direct sunlight can make the cabin extremely warm, and even after cooling down the interior temperature, combating the continuous stream of sunlight and heat is a challenge. It uses precious energy that is especially pertinent to range and efficiency.

The patent explains how standard dashboard vents push cool air upward, only to entrain warmer air from these stagnant zones and distribute it throughout the occupied cabin space. This process forces the blower to operate at higher speeds, increasing energy consumption and reducing overall efficiency.

In electric vehicles, where every watt impacts driving range, such inefficiencies prove costly.

Research from AAA indicates that air conditioning can diminish range by up to 17 percent under hot conditions. Tesla’s innovation shifts the approach by extracting heat at its source rather than attempting to dilute it after mixing occurs.

Engineers describe a suction HVAC unit connected to dedicated intakes positioned strategically on the upper dashboard surface and within the headliner.

These intakes link to a hot air pocket extraction duct that channels the warmest air directly into the system’s plenum for conditioning. As the blower activates, it simultaneously draws recirculated cabin air and targeted hot pocket air through filters and cooling coils before redistributing conditioned airflow.

It seems somewhat reminiscent of the Tesla heat pump, which aims to combat colder temperatures.

Tesla highlights Model Y’s heat pump innovations in new promotional video

This method reduces entrainment, lowers peak temperatures, and achieves more uniform comfort levels. Testing data reveals that facial temperature gradients drop from 21 degrees Celsius, or 69.8 degrees Fahrenheit, in conventional setups to just 12 degrees Celsius (53.6 degrees F) with the new system. Blower speeds and compressor power requirements decrease appreciably as a result.

The design incorporates smart controls that monitor sunlight intensity and internal temperature distributions in real time. Suction activates selectively only where needed, optimizing energy use without constant high demand. Furthermore, the extraction duct serves a dual purpose.

In the summer months, it pulls hot air inward for cooling; in winter, it reverses to direct warm air outward for rapid windshield defrosting. This versatility allows the reuse of existing hardware with minimal modifications, potentially enabling retrofits in current Tesla fleets.

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Tesla saves its passengers again – This time after a 300-foot cliff fall in Malibu

A Tesla Model 3 fell 300 feet off a Malibu cliff and both passengers survived.

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A Tesla Model 3 plunged roughly 300 feet off a cliff on Mulholland Highway in Malibu on Friday morning, May 29, 2026, and both occupants survived. The crash was reported at approximately 7:30 a.m. near the 2500 block of Mulholland Highway, triggering a multi-agency rescue operation involving Malibu Search and Rescue, the Los Angeles County Fire Department, the California Highway Patrol, and McCormick Ambulance.

When first responders arrived, the male driver was outside the vehicle shouting for help while the female passenger remained pinned inside the Tesla. Rescue crews rappelled down the cliffside on ropes to reach the wreckage. A flight medic was lowered by helicopter to begin treating both victims, and the driver was hoisted up to the roadway before crews used the Jaws of Life to free the trapped passenger. Both were airlifted to a local trauma center with moderate injuries despite a remarkable result for a fall that steep.

The outcome is not surprising, considering Model 3 earned an overall 5-star rating from NHTSA in every category and sub-category, and recorded the lowest probability of injury of any car ever evaluated by the U.S. New Car Assessment Program. The absence of a traditional engine in the front of the vehicle creates a longer crumple zone that absorbs impact energy before it reaches occupants, and the battery pack running along the floor gives the car an unusually low center of gravity that reinforces structural rigidity.

This is not the first time a Tesla has kept passengers alive after going off a cliff. A Tesla Model Y carrying a family of four survived a plunge off a cliff at Devil’s Slide near San Francisco in January 2023, with two adults and two children walking away from a 250-foot fall. That incident drew widespread attention to how the structural integrity of Tesla’s electric platform performs in extreme crash scenarios that most vehicles would not survive.

Tesla Model Y driver who drove off cliff with family attempts to avoid criminal conviction

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Tesla Full Self-Driving expansion in Europe continues with new addition

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Credit: Tesla

Tesla Full Self-Driving (Supervised) has taken yet another significant step forward in Europe. On May 29, Estonia became the third European Union country to approve the advanced driver-assistance technology, following approvals in the Netherlands and Lithuania.

Tesla Europe announced the news on X, confirming the expansion has continued across the continent that, at one time, seemed to be taking its sweet old time giving any approval to the FSD suite.

Estonia’s Transport Administration (Transpordiamet) granted the approval by recognizing the type certification issued by the Dutch vehicle authority RDW. This mutual recognition mechanism, enabled by EU regulations, allows other member states to fast-track deployment without repeating extensive local testing.

The Estonian authority noted that Tesla’s FSD had undergone rigorous evaluation on European roads for approximately 18 months before the initial Dutch approval in April 2026.

FSD Supervised remains classified as a Level 2 advanced driver-assistance system (ADAS). Drivers must maintain full attention, keep their hands on the wheel, and stay ready to intervene at any moment.

The system assists with tasks such as automatic lane changes, navigation through city streets, and responding to traffic objects, but it does not constitute full autonomy. Estonian officials emphasized this distinction, underscoring that safety responsibility lies entirely with the driver.

The rapid progression across the Baltic region highlights Tesla’s strategic approach to European expansion. The Netherlands provided the foundational type approval in April, unlocking doors for neighboring countries.

Lithuania followed swiftly in mid-May, with rollout beginning shortly thereafter. Estonia’s decision, coming just days later, demonstrates how smaller, digitally progressive nations are accelerating adoption.

Tesla owners in Estonia can expect an over-the-air software update in the coming weeks, bringing the latest FSD capabilities to compatible vehicles

This expansion builds on Tesla’s global momentum. FSD Supervised is now available in 11 countries worldwide, including the United States, Canada, Australia, and South Korea. In Europe, the approvals signal growing regulatory confidence in Tesla’s vision-based AI approach, which relies on cameras and neural networks rather than lidar or radar-heavy alternatives used by some competitors.

For Tesla, these European milestones are more than symbolic. They validate years of data collection and software iteration while opening new revenue streams through FSD subscriptions and purchases.

As the company continues refining its AI models with real-world miles from diverse driving environments, including Estonia’s variable winter conditions, the dataset grows richer, potentially benefiting global users.

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