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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.
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Tesla starts showing how FSD will change lives in Europe
Local officials tested the system on narrow country roads and were impressed by FSD’s smooth, human-like driving, with some calling the service a game-changer for everyday life in areas that are far from urban centers.
Tesla has launched Europe’s first public shuttle service using Full Self-Driving (Supervised) in the rural Eifelkreis Bitburg-Prüm region of Germany, demonstrating how the technology can restore independence and mobility for people who struggle with limited transport options.
Local officials tested the system on narrow country roads and were impressed by FSD’s smooth, human-like driving, with some calling the service a game-changer for everyday life in areas that are far from urban centers.
Officials see real impact on rural residents
Arzfeld Mayor Johannes Kuhl and District Administrator Andreas Kruppert personally tested the Tesla shuttle service. This allowed them to see just how well FSD navigated winding lanes and rural roads confidently. Kruppert said, “Autonomous driving sounds like science fiction to many, but we simply see here that it works totally well in rural regions too.” Kuhl, for his part, also noted that FSD “feels like a very experienced driver.”
The pilot complements the area’s “Citizen Bus” program, which provides on-demand rides for elderly residents who can no longer drive themselves. Tesla Europe shared a video of a demonstration of the service, highlighting how FSD gives people their freedom back, even in places where public transport is not as prevalent.
What the Ministry for Economic Affairs and Transport says
Rhineland-Palatinate’s Minister Daniela Schmitt supported the project, praising the collaboration that made this “first of its kind in Europe” possible. As per the ministry, the rural rollout for the service shows FSD’s potential beyond major cities, and it delivers tangible benefits like grocery runs, doctor visits, and social connections for isolated residents.
“Reliable and flexible mobility is especially vital in rural areas. With the launch of a shuttle service using self-driving vehicles (FSD supervised) by Tesla in the Eifelkreis Bitburg-Prüm, an innovative pilot project is now getting underway that complements local community bus services. It is the first project of its kind in Europe.
“The result is a real gain for rural mobility: greater accessibility, more flexibility and tangible benefits for everyday life. A strong signal for innovation, cooperation and future-oriented mobility beyond urban centers,” the ministry wrote in a LinkedIn post.
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Tesla China quietly posts Robotaxi-related job listing
Tesla China is currently seeking a Low Voltage Electrical Engineer to work on circuit board design for the company’s autonomous vehicles.
Tesla has posted a new job listing in Shanghai explicitly tied to its Robotaxi program, fueling speculation that the company is preparing to launch its dedicated autonomous ride-hailing service in China.
As noted in the listing, Tesla China is currently seeking a Low Voltage Electrical Engineer to work on circuit board design for the company’s autonomous vehicles.
Robotaxi-specific role
The listing, which was shared on social media platform X by industry watcher @tslaming, suggested that Tesla China is looking to fill the role urgently. The job listing itself specifically mentions that the person hired for the role will be working on the Low Voltage Hardware team, which would design the circuit boards that would serve as the nervous system of the Robotaxi.
Key tasks for the role, as indicated in the job listing, include collaboration with PCB layout, firmware, mechanical, program management, and validation teams, among other responsibilities. The role is based in Shanghai.
China Robotaxi launch
China represents a massive potential market for robotaxis, with its dense urban centers and supportive policies in select cities. Tesla has limited permission to roll out FSD in the country, though despite this, its vehicles have been hailed as among the best in the market when it comes to autonomous features. So far, at least, it appears that China supports Tesla’s FSD and Robotaxi rollout.
This was hinted at in November, when Tesla brought the Cybercab to the 8th China International Import Expo (CIIE) in Shanghai, marking the first time that the autonomous two-seater was brought to the Asia-Pacific region. The vehicle, despite not having a release date in China, received a significant amount of interest among the event’s attendees.
Elon Musk
Elon Musk and Tesla AI Director share insights after empty driver seat Robotaxi rides
The executives’ unoccupied tests hint at the rapid progress of Tesla’s unsupervised Robotaxi efforts.
Tesla CEO Elon Musk and AI Director Ashok Elluswamy celebrated Christmas Eve by sharing personal experiences with Robotaxi vehicles that had no safety monitor or occupant in the driver’s seat. Musk described the system’s “perfect driving” around Austin, while Elluswamy posted video from the back seat, calling it “an amazing experience.”
The executives’ unoccupied tests hint at the rapid progress of Tesla’s unsupervised Robotaxi efforts.
Elon and Ashok’s firsthand Robotaxi insights
Prior to Musk and the Tesla AI Director’s posts, sightings of unmanned Teslas navigating public roads were widely shared on social media. One such vehicle was spotted in Austin, Texas, which Elon Musk acknowleged by stating that “Testing is underway with no occupants in the car.”
Based on his Christmas Eve post, Musk seemed to have tested an unmanned Tesla himself. “A Tesla with no safety monitor in the car and me sitting in the passenger seat took me all around Austin on Sunday with perfect driving,” Musk wrote in his post.
Elluswamy responded with a 2-minute video showing himself in the rear of an unmanned Tesla. The video featured the vehicle’s empty front seats, as well as its smooth handling through real-world traffic. He captioned his video with the words, “It’s an amazing experience!”
Towards Unsupervised operations
During an xAI Hackathon earlier this month, Elon Musk mentioned that Tesla owed be removing Safety Monitors from its Robotaxis in Austin in just three weeks. “Unsupervised is pretty much solved at this point. So there will be Tesla Robotaxis operating in Austin with no one in them. Not even anyone in the passenger seat in about three weeks,” he said. Musk echoed similar estimates at the 2025 Annual Shareholder Meeting and the Q3 2025 earnings call.
Considering the insights that were posted Musk and Elluswamy, it does appear that Tesla is working hard towards operating its Robotaxis with no safety monitors. This is quite impressive considering that the service was launched just earlier this year.
Tesla starts showing how FSD will change lives in Europe
Tesla China quietly posts Robotaxi-related job listing
