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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.
Elon Musk
SpaceX targets 150Mbps per user for upgraded Starlink Direct-to-Cell
If achieved, the 150Mbps goal would represent a significant jump from the current performance of Starlink Direct-to-Cell.
SpaceX is targeting peak download speeds of 150Mbps per user for its next-generation Direct-to-Cell Starlink service. The update was shared by SpaceX Spectrum & Regulatory Affairs Lead Udrivolf Pica during the International Telecommunication Union’s Space Connect conference.
“We are aiming at peak speeds of 150Mbps per user,” Pica said during the conference. “So something incredible if you think about the link budgets from space to the mobile phone.”
If achieved, the 150Mbps goal would represent a significant jump from the current performance of Starlink Direct-to-Cell.
Today, SpaceX’s cellular Starlink service, offered in partnership with T-Mobile under the T-Satellite brand, provides speeds of roughly 4Mbps per user. The service is designed primarily for texts, low-resolution video calls, and select apps in locations that traditionally have no cellular service.
By comparison, Ookla data shows median 5G download speeds of approximately 309Mbps for T-Mobile and 172Mbps for AT&T in the United States, as noted in a PCMag report. While 150Mbps would still trail the fastest terrestrial 5G networks, it would place satellite-to-phone broadband much closer to conventional carrier performance, even in remote areas.
Pica indicated that the upgraded system would support “video, voice, and data services, clearly,” moving beyond emergency connectivity and basic messaging use cases.
To reach that target, SpaceX plans to upgrade its existing Starlink Direct-to-Cell satellites and add significant new capacity. The company recently acquired access to radio spectrum from EchoStar, which Pica described as key to expanding throughput.
“More spectrum means a bigger pipeline, and this means that we can expand what we can do with partners. We can expand the quality of service. And again, we can do cellular broadband basically, cellular broadband use cases, like AI or daily connectivity needs,” he stated.
SpaceX has also requested regulatory approval to deploy 15,000 additional Direct-to-Cell satellites, beyond the roughly 650 currently supporting the system. The upgraded architecture is expected to begin rolling out in late 2027.
News
Tesla seeks approval to test FSD Supervised in new Swedish city
Tesla has applied to conduct local Full Self-Driving (Supervised) testing in the city of Jönköping, Sweden.
Tesla has applied to conduct local Full Self-Driving (Supervised) testing in the city of Jönköping, Sweden.
As per local outlet Jönköpings-Posten, Tesla has contacted the municipality with a request to begin FSD (Supervised) tests in the city. The company has already received approval to test its Full Self-Driving (Supervised) software in several Swedish municipalities, as well as on the national road network.
Sofia Bennerstål, Tesla’s Head of Public Policy for Northern Europe, confirmed that an application has been submitted for FSD’s potential tests in Jönköping.
“I can confirm that we have submitted an application, but I cannot say much more about it,” Bennerstål told the news outlet. She also stated that Tesla is “satisfied with the tests” in the region so far.
The planned tests in Jönköping would involve a limited number of Tesla-owned vehicles. Trained Tesla safety drivers would remain behind the wheel and be prepared to intervene if necessary.
Tesla previously began testing in Nacka municipality after receiving local approval. At the time, the company stated that cooperation between authorities, municipalities, and industry enables technological progress and helps integrate future transport systems into real-world traffic conditions, as noted in an Allt Om Elbil report.
If approved, Jönköping would become the latest Swedish municipality to allow local Full Self-Driving (Supervised) testing.
Tesla’s Swedish testing program is part of the company’s efforts to validate its supervised autonomous driving software in everyday traffic environments. Municipal approvals allow Tesla to gather data in urban settings that include roundabouts, complex intersections, and mixed traffic conditions.
Sweden has become an increasingly active testing ground for Tesla’s driver-assistance software in Europe, with regulatory coordination between local authorities and national agencies enabling structured pilot programs.
Elon Musk
Microsoft partners with Starlink to expand rural internet access worldwide
The update was shared ahead of Mobile World Congress.
Microsoft has announced a new collaboration with Starlink as part of its expanding digital access strategy, following the company’s claim that it has extended internet connectivity coverage to more than 299 million people worldwide.
The update was shared ahead of Mobile World Congress, where Microsoft detailed how it surpassed its original goal of bringing internet access to 250 million people by the end of 2025.
In a blog post, Microsoft confirmed that it is now working with Starlink to expand connectivity in rural and hard-to-reach regions.
“Through our collaboration with Starlink, Microsoft is combining low-Earth orbit satellite connectivity with community-based deployment models and local ecosystem partnerships,” the company wrote.
The partnership is designed to complement Microsoft’s existing work with local internet providers and infrastructure companies across Africa, Latin America, and India, among other areas. Microsoft noted that traditional infrastructure alone cannot meet demand in some regions, making low-Earth orbit satellite connectivity an important addition.
Kenya was cited as an early example. Working with Starlink and local provider Mawingu Networks, Microsoft is supporting connectivity for 450 community hubs in rural and underserved areas. These hubs include farmer cooperatives, aggregation centers, and digital access facilities intended to support agricultural productivity and AI-enabled services.
Microsoft stated that 2.2 billion people globally remain offline, and that connectivity gaps risk widening as AI adoption accelerates.
Starlink’s expanding constellation, now numbering more than 9,700 satellites in orbit, provides near-global coverage, making it one of the few systems capable of delivering broadband to remote regions without relying on terrestrial infrastructure.
Starlink is expected to grow even more in the coming years as well, especially as SpaceX transitions its fleet to Starship, which is capable of carrying significantly larger payloads compared to its current workhorse, the Falcon 9.