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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 hiring Body Fit Technicians for Cybercab’s end of line
As per Tesla’s Careers website, Body Fit Technicians for the Cybercab focus on precision body fitment work, including alignment, gap and flush adjustments.
Tesla has posted job openings for Body Fit Technicians for the Cybercab’s end-of-line assembly, an apparent indication that preparations for the vehicle’s initial production are accelerating at Giga Texas.
Body Fit Technicians for Cybercab line
As per Tesla’s Careers website, Body Fit Technicians for the Cybercab focus on precision body fitment work, including alignment, gap and flush adjustments, and certification of body assemblies to specification standards.
Employees selected for the role will collaborate with engineering and quality teams to diagnose and correct fitment and performance issues and handle detailed inspections, among other tasks.
The listing noted that candidates should be experienced with automotive body fit techniques and comfortable with physically demanding tasks such as lifting, bending, walking, and using both hand and power tools. The position is based in Austin, Texas, where Tesla’s main Cybercab production infrastructure is being built.
Cybercab poised for April production
Tesla CEO Elon Musk recently reiterated that the Cybercab is still expected to start initial production this coming April. So far, numerous Cybercab test units have been spotted across the United States, and recent posts from the official Tesla Robotaxi account have revealed that winter tests in Alaska for the autonomous two-seater are underway.
While April has been confirmed as the date for the Cybercab’s initial production, Elon Musk has also set expectations about the vehicle’s volumes in its initial months. As per the CEO, the Cybercab’s production will follow a typical S-curve, which means that early production rates for the vehicle will be very limited.
“Initial production is always very slow and follows an S-curve. The speed of production ramp is inversely proportionate to how many new parts and steps there are. For Cybercab and Optimus, almost everything is new, so the early production rate will be agonizingly slow, but eventually end up being insanely fast,” Musk wrote in a post on X.
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Swedish unions consider police report over Tesla Megapack Supercharger
The Tesla Megapack Supercharger opened shortly before Christmas in Arlandastad, outside Stockholm.
Swedish labor unions are considering whether to file a police report related to a newly opened Tesla Megapack Supercharger near Stockholm, citing questions about how electricity is supplied to the site. The matter has also been referred to Sweden’s energy regulator.
Tesla Megapack Supercharger
The Tesla Megapack Supercharger opened shortly before Christmas in Arlandastad, outside Stockholm. Unlike traditional charging stations, the site is powered by an on-site Megapack battery rather than a direct grid connection. Typical grid connections for Tesla charging sites in Sweden have seen challenges for nearly two years due to union blockades.
Swedish labor union IF Metall has submitted a report to the Energy Market Inspectorate, asking the authority to assess whether electricity supplied to the battery system meets regulatory requirements, as noted in a report from Dagens Arbete (DA). The Tesla Megapack on the site is charged using electricity supplied by a local company, though the specific provider has not been publicly identified.
Peter Lydell, an ombudsman at IF Metall, issued a comment about the Tesla Megapack Supercharger. “The legislation states that only companies that engage in electricity trading may supply electricity to other parties. You may not supply electricity without a permit, then you are engaging in illegal electricity trading. That is why we have reported this… This is about a company that helps Tesla circumvent the conflict measures that exist. It is clear that it is troublesome and it can also have consequences,” Lydell said.
Police report under consideration
The Swedish Electricians’ Association has also examined the Tesla Megapack Supercharger and documented its power setup. As per materials submitted to the Energy Market Inspectorate, electrical cables were reportedly routed from a property located approximately 500 meters from the charging site.
Tomas Jansson, ombudsman and deputy head of negotiations at the Swedish Electricians’ Association, stated that the union was assessing whether to file a police report related to the Tesla Megapack Supercharger. He also confirmed that the electricians’ union was coordinating with IF Metall about the matter. “We have a close collaboration with IF Metall, and we are currently investigating this. We support IF Metall in their fight for fair conditions at Tesla,” Jansson said.
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Tesla HW4.5 spotted in new Model Y, triggers speculation
Owners taking delivery of recent Model Y builds have identified components labeled “AP45.”
Tesla’s Hardware 4.5 computer appears to have surfaced in newly delivered Model Y vehicles, prompting fresh speculation about an interim upgrade ahead of the company’s upcoming AI5 chip.
Owners taking delivery of recent Model Y builds have identified components labeled “AP45,” suggesting Tesla may have quietly started rolling out revised autonomy hardware.
Hardware 4.5 appears in new Model Y units
The potential Hardware 4.5 sighting was first reported by Model Y owner @Eric5un, who shared details of a Fremont-built 2026 Model Y AWD Premium delivered this January. As per the Model Y owner, the vehicle includes a new front camera housing and a 16-inch center display, along with an Autopilot computer labeled “AP45” and part number 2261336-02-A.
The Tesla owner later explained that he confirmed the part number by briefly pulling down the upper carpet liner below the Model Y’s glovebox. Other owners soon reported similar findings. One Model Y Performance owner noted that their December build also appeared to include Hardware 4.5, while another owner of an Austin-built Model Y Performance reported spotting the same “AP45” hardware.
These sightings suggest that Tesla may already be installing revised FSD computers in its new Model Y batches, despite the company not yet making any formal announcements about Hardware 4.5.
What Hardware 4.5 could represent
Clues about Hardware 4.5 have surfaced previously in Tesla’s Electronic Parts Catalog. As reported by NotATeslaApp, the catalog has listed a component described as “CAR COMPUTER – LEFT HAND DRIVE – PROVISIONED – HARDWARE 4.5.” The component, which features the part number 2261336-S2-A, is priced at $2,300.00.
Longtime Tesla hacker @greentheonly has noted that Tesla software has contained references to a possible three-SoC architecture for some time. Previous generations of Tesla’s FSD computer, including Hardware 3 and Hardware 4, use a dual-SoC design for redundancy. A three-SoC layout could allow for higher inference throughput and improved fault tolerance.
Such an architecture could also serve as a bridge to AI5, Tesla’s next-generation autonomy chip expected to enter production later in 2026. As Tesla’s neural networks grow larger and more computationally demanding, Hardware 4.5 may provide additional headroom for vehicles built before AI5 becomes widely available.
