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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 teasing and hyping groundbreaking Cybercab event
Tesla is starting to truly tease and hype its groundbreaking Cybercab event, which takes place tomorrow in Austin, Texas. It will be the first time members of the public will be able to ride in a Cybercab, a vehicle without any manual controls, on public roads.
Tesla has been dropping some hype on X over the past several days, but this morning, the excitement has truly started to build up for the event. Although Cybercab has been unveiled before, this is truly Tesla’s announcement that it is ready to start offering autonomous rides for public passengers in its new ride-hailing-geared vehicle for the first time.
The hype has started with a variety of different social media posts that are a true indication that Tesla is preparing for something big. Teasing so much of the potential of Cybercab, including its ability to truly revolutionize how people hail rides for local travel, is what the big idea for the event entails. The time that many Tesla owners, fans, and investors have been waiting for is potentially here:
— Tesla (@Tesla) September 2, 2026
The event has remained slim on details. Even invitees are still awaiting true details about what the event will entail, where they’ll go, and what is in store for the evening. This is pretty typical for an event run by Tesla; they keep things under wraps for the most part until the very last minute.
However, there is no secret about what the real intention of Tesla is for this event: it is going to be a huge reveal party for a vehicle that has no steering wheel and no pedals. It is a truly massive step for the company moving forward.
No steering wheel, no pedals
— Tesla Robotaxi (@robotaxi) September 2, 2026
Speculation persists as to whether this is going to be an event that simply announces that rides will begin with the Cybercab, or it will be something more substantial. Tesla has said in the past that they plan to sell the Cybercab to the general public in what could become a great way to earn passive income by adding it to a more global fleet of Robotaxi-geared vehicles.
Tomorrow, the show begins in Austin, and the Cybercab goes live at some capacity; we just don’t know exactly how quite yet.
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SpaceX tells the FCC that Starship Flight 14 is going to orbit
SpaceX filed with the FCC for Starship Flight 14, its first true orbital launch attempt.
SpaceX has asked the Federal Communications Commission for permission to fly Starlink terminals during Starship’s fourteenth flight test, and the filing lays out a genuine trip to orbit, something the program has never attempted.
Every Starship flight so far, including Flight 13’s successful splashdown in the Indian Ocean on July 24, has flown a suborbital arc that ends with the ship reentering the atmosphere within the same hour it launches. The FCC paperwork describes a mission profile built around an actual orbital insertion instead.
The payload is the other half of the story. Flight 13 carried 20 production Starlink V3 satellites, but because that mission never reached orbit, the satellites reentered along with the ship rather than joining the constellation, something Teslarati covered in detail after SpaceX released footage shot from one of those satellites as it drifted away from Starship in space. Flight 14 is designed to close that gap. If the orbital insertion holds, the roughly 20 V3 satellites onboard would separate into an operational orbit and could eventually go into service, each one rated for about 1 terabit per second of downlink capacity by SpaceX’s own account.
SpaceX announces new Starbase for ‘thousands of Starship launches annually’
Elon Musk first flagged the orbital attempt during SpaceX’s August 4 earnings call, the company’s first as a public entity following its June IPO under the ticker SPCX. He also floated catching the ship with the Starbase tower on the same flight, an idea he walked back on August 20, saying the catch attempt would more likely come “in a few months,” as Teslarati reported at the time. Flight 14 will instead target a splashdown for the ship in the Indian Ocean, the same recovery method used since Flight 12.
Hardware has been catching up to the ambition. Booster 21 completed a full 33-engine static fire on August 28, and Ship 41 finished its own six-engine test the week before. An airspace briefing circulated to pilots on August 20 listed September 15 as the target date, later than the end of August window Musk mentioned on the earnings call, though SpaceX has not confirmed a launch date publicly and Starship schedules routinely slip while hardware and FAA paperwork line up.
The FCC filing itself does not guarantee a launch date. It covers communications authority, and not flight readiness, considering SpaceX still needs Ship 41 fully stacked and cleared by the FAA before Flight 14 can fly. But the filing is a real marker of intent and it puts a specific regulatory process behind what had so far only been Musk’s word on the earnings call.
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Tesla Cybercab Event: what to expect from Austin
Tesla is set to launch Cybercab on Thursday at an event in Austin, Texas, which will officially bring the company’s first steering wheel-less and pedal-less vehicle to a limited number of consumers for the first time.
The event, which is invite-only, is still thin on details: we’ll be there, and it seems the event will be held at Gigafactory Texas, but the launch of this vehicle truly relies on it being operational outside of the factory and on public roads.
🚨 Close-Up look at Tesla Cybercab without steering wheel: pic.twitter.com/9TXCDeDCz7
— TESLARATI (@Teslarati) July 3, 2026
Nevertheless, there are some big things to expect, and other things to temper expectations on. For what it’s worth, we believe this event could be perhaps the biggest indication that Tesla is ready to truly enter a new phase and chapter in its historic story.
Tesla Cybercab’s First Foray into the Public with Real-World Riders
Cybercab will likely hit the streets of Austin and the surrounding areas, likely in the established geofence that Tesla has expanded on for the past 14 months. Just yesterday, Tesla expanded it once again by 9 percent.
Tesla will put, for the first time, a vehicle without any manual controls on public roads, likely without any help from teleoperators. This is a truly groundbreaking development if it comes through in this fashion: it would be groundbreaking for Tesla to roll out a truly driverless ride-hailing vehicle.
Cybercab Has Already Been Unveiled
This is not an unveiling event. Cybercab has been released for nearly two years, as Tesla first showed it to the public on October 10, 2024.
FIRST LOOK: Tesla ‘Cybercab’ Robotaxi makes its global debut
While there is some small speculation that Tesla could release the Roadster at the event as a surprise, it seems more likely the focus will be on the Cybercab and the huge accomplishment that will come with releasing a vehicle with no manual controls.
There Will Be a Lot of Hype
What’s important to remember about the Cybercab event is that Tesla will continue to prioritize safety and the rollout will likely be slow, just as it has been with Robotaxi.
One of the biggest complaints about Robotaxi is vehicle population, and the fact that the wait for a ride, at least in some instances, has been longer than most want to admit.
It will take time for this project to truly scale. It will take time for Tesla to roll this out in a large fashion. The important thing to note is that they are doing it, and they’re doing it with a vehicle that is completely engineered and built internally. That’s something no other ride-hailing service can say.