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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 Cybercab tests are going on overdrive with production-ready units
Tesla is ramping its real-world tests of the Cybercab, with multiple sightings of the vehicle being reported across social media this week.
Tesla is ramping its real-world tests of the Cybercab, with multiple sightings of the autonomous two-seater being reported across social media this week. Based on videos of the vehicle that have been shared online, it appears that Cybercab tests are underway across multiple states.
Recent Cybercab sightings
Reports of Cybercab tests have ramped this week, with a vehicle that looked like a production-ready prototype being spotted at Apple’s Visitor Center in California. The vehicle in this sighting was interesting as it was equipped with a steering wheel. The vehicle also featured some changes to the design of its brake lights.
The Cybercab was also filmed testing at the Fremont factory’s test track, which also seemed to involve a vehicle that looked production-ready. This also seemed to be the case for a Cybercab that was spotted in Austin, Texas, which happened to be undergoing real-world tests. Overall, these sightings suggest that Cybercab testing is fully underway, and the vehicle is really moving towards production.
Production design all but finalized?
Recently, a near-production-ready Cybercab was showcased at Tesla’s Santana Row showroom in San Jose. The vehicle was equipped with frameless windows, dual windshield wipers, powered butterfly door struts, an extended front splitter, an updated lightbar, new wheel covers, and a license plate bracket. Interior updates include redesigned dash/door panels, refined seats with center cupholders, updated carpet, and what appeared to be improved legroom.
There seems to be a pretty good chance that the Cybercab’s design has been all but finalized, at least considering Elon Musk’s comments at the 2025 Annual Shareholder Meeting. During the event, Musk confirmed that the vehicle will enter production around April 2026, and its production targets will be quite ambitious.
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Tesla gets a win in Sweden as union withdraws potentially “illegal” blockade
As per recent reports, the Vision union’s planned anti-Tesla action might have been illegal.
Swedish union Vision has withdrawn its sympathy blockade against Tesla’s planned service center and showroom in Kalmar. As per recent reports, the Vision union’s planned anti-Tesla action might have been illegal.
Vision’s decision to pull the blockade
Vision announced the blockade in early December, stating that it was targeting the administrative handling of Tesla’s facility permits in Kalmar municipality. The sympathy measure was expected to start Monday, but was formally withdrawn via documents sent to the Mediation Institute and Kalmar Municipality last week.
As noted in a Daggers Arbete report, plans for the strike were ultimately pulled after employer group SKR highlighted potential illegality under the Public Employment Act. Vision stressed its continued backing for the Swedish labor model, though Deputy negotiation manager Oskar Pettersson explained that the Vision union and IF Metall made the decision to cancel the planned strike together.
“We will not continue to challenge the regulations,” Petterson said. “The objection was of a technical nature. We made the assessment together with IF Metall that we were not in a position to challenge the legal assessment of whether we could take this particular action against Tesla. Therefore, we chose to revoke the notice itself.”
The SKR’s warning
Petterson also stated that SKR’s technical objection to the Vision union’s planned anti-Tesla strike framed the protest as an unauthorized act. “It was a legal assessment of the situation. Both for us and for IF Metall, it is important to be clear that we stand for the Swedish model. But we should not continue to challenge the regulations and risk getting judgments that lead nowhere in the application of the regulations,” he said.
Vision ultimately canceled its planned blockade against Tesla on December 9. With Vision’s withdrawal, few obstacles remain for Tesla’s long-planned Kalmar site. A foreign electrical firm completed work this fall, and Tesla’s Careers page currently lists a full-time service manager position based there, signaling an imminent opening.
Tesla Semi Program Director Dan Priestly teased the major improvements to the all-electric Class 8 truck on Thursday night, following the company’s decision to overhaul the design earlier this year.
Priestley said he drove the Semi on Thursday, and the improvements appear to be welcomed by one of the minds behind the project. “Our customers are going to love it,” he concluded.
Just drove the redesigned Semi. Our customers are going to love it. https://t.co/KZ88sf1CDL
— Dan Priestley (@danWpriestley) December 19, 2025
The small detail does not seem like much, but it is coming from someone who has been involved in the development of the truck from A to Z. Priestley has been involved in the Semi program since November 2015 and has slowly worked his way through the ranks, and currently stands as the Director of the program.
Tesla Semi undergoes major redesign as dedicated factory preps for deliveries
Tesla made some major changes to the Semi design as it announced at the 2025 Annual Shareholder Meeting that it changed the look and design to welcome improvements in efficiency.
Initially, Tesla adopted the blade-like light bar for the Semi, similar to the one that is present on the Model Y Premium and the Cybertruck.
Additionally, there are some slight aesthetic changes to help with efficiency, including a redesigned bumper with improved aero channels, a smaller wraparound windshield, and a smoother roofline for better aero performance.
All of these changes came as the company’s Semi Factory, which is located on Gigafactory Nevada’s property, was finishing up construction in preparation for initial production phases, as Tesla is planning to ramp up manufacturing next year. CEO Elon Musk has said the Semi has attracted “ridiculous demand.”
The Semi has already gathered many large companies that have signed up to buy units, including Frito-Lay and PepsiCo., which have been helping Tesla test the vehicle in a pilot program to test range, efficiency, and other important metrics that will be a major selling point.
Tesla will be the Semi’s first user, though, and the truck will help solve some of the company’s logistics needs in the coming years.
Tesla Cybercab tests are going on overdrive with production-ready units
Tesla gets a win in Sweden as union withdraws potentially “illegal” blockade
