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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.
Tesla is delaying its event for the Roadster, moving it from this Thursday, October 1, to Thursday, October 15, due to unfavorable weather.
The company has said it has been tracking the weather for this Thursday closely with local meteorologists, and because the event can only be held outside, Tesla is making the call to delay it:
“We’ve been tracking the weather closely with local meteorologists, but given the severe conditions predicted & because this event can only be held outdoors, we’ve made the difficult decision to reschedule. New date is October 15. Additional details to follow.”
Roadster event update
We’ve been tracking the weather closely with local meteorologists, but given the severe conditions predicted & because this event can only be held outdoors, we’ve made the difficult decision to reschedule.
New date is October 15. Additional details to…
— Tesla (@Tesla) September 28, 2026
We are sure that this is bringing back PTSD for some Tesla fans, and we know it is not ideal, but this also reveals some things about the event. Tesla said that this can only be held outdoors, meaning it bodes well for the rumors that the vehicle could potentially hover.
Some believe that this was essentially confirmed by the FAA airspace restriction they were granted, but this could have been for a drone show or to keep drones from spying on the event.
Tesla Roadster is available for order once again following brief hold
The Roadster event has been long-awaited, and it is unfortunate that the weather is going to keep us all waiting a little bit longer.
The Tesla Roadster will be unveiled in Waco, Texas.
Elon Musk
SpaceX turned a heralding moment for Starship into its greatest
Starship reached orbit despite losing an engine, deployed 26 Starlink V3 satellites on Flight 14.
SpaceX’s Starship reached orbit for the first time on Monday, and for a few nail-biting minutes it looked like it wouldn’t. During ascent on Flight 14, one of Ship 41’s six Raptor engines shut down early, and SpaceX’s livestream host Dan Huot told viewers the team had decided not to commit to orbit. Minutes later, after what Huot described as a lot of conversation in the control room, the final poll came back in favor, and a roughly 19 second burn of a single Raptor pushed the ship into orbit about 170 miles up.
The reversal matters because SpaceX had written the exit ramp into the mission plan. The company said it would only fire the orbital insertion burn if flight controllers confirmed enough backup hardware remained for the deorbit burn, a condition Teslarati laid out ahead of the flight. Losing an engine was exactly the scenario that rule was built for.
Pressing forward fits Elon Musk’s history. Falcon 1 failed three straight times before its fourth launch reached orbit in 2008, with SpaceX nearly out of money, and Starship was developed by flying prototypes until they broke. What changed this year SpaceX going public, and with $SPCX sliding below its IPO price in July when Flight 13 slipped, the short interest climbed significantly, as Teslarati reported at the time. A Starship potentially lost today with revenue generating next-gen Starlink satellites aboard would have landed directly on shareholders.
Splashdown confirmed. Congratulations to the entire SpaceX team on the first orbital flight of Starship! pic.twitter.com/urjmiwnvNl
— SpaceX (@SpaceX) September 28, 2026
That pressure showed up after orbit. SpaceX cut a flight planned to last nearly 10 hours to about three, moving splashdown from west of Chile to the North Pacific near Hawaii. SpaceX gave no reason, though Musk said this month the company was being extremely cautious about debris risk. The single Raptor for deorbit worked, and Ship 41 completed its flip and landing burn before breaking apart in the water, an outcome SpaceX expected. Musk has structured SpaceX’s governance to shield long term bets from market pressure.
The payload is the bigger business story. Musk posted that all 26 Starlink V3 satellites deployed and are “operating nominally.” Each V3 is rated for about 1 Tbps of downlink and 160 Gbps of uplink, so this single launch adds roughly 26 Tbps, about 10 times what a Falcon 9 load of V2 Mini satellites adds. The V3 is too large for Falcon 9, making Starship the only vehicle that can build out the planned 100,000 satellite constellation, at up to 60 per flight once it reaches routine service. Unlike the 20 V3 units on Flight 13, which reentered on a suborbital path, these will raise their orbits and could begin serving customers within weeks and bring in hundreds of millions of additional dollars in projected Starlink revenue.
SpaceX has already begun winding down Falcon 9 Starlink launches from Florida in favor of Starship. Reported targets put Flight 15 as early as October 19, leaving about three weeks to diagnose Monday’s engine shutdown before the next orbital attempt.
Starship’s 14th flight is set to launch on Monday, Sept 28. The 75-minute launch window opens at 7:15 a.m. CT. Live coverage of the mission starts ~35 minutes before launch → https://t.co/uQKQvgaTmJ
— SpaceX (@SpaceX) September 27, 2026
Tesla quietly doubled the size of its Cybercab fleet within the Robotaxi program in Austin, Texas, over the weekend to well over 100 units.
The move not only establishes more of the steering-wheel-less and pedal-less vehicles within the ride-sharing fleet Tesla has been operating for a year, but it also solidifies a more robust Robotaxi fleet as a whole.
Riders started receiving notifications from the Robotaxi app that stated: “Cybercab fleet has doubled: more rides available.”
I got this notification on the robotaxi app. They are saying the Cybercab fleet has doubled. Glad that they are advertising this pic.twitter.com/FFrnw4FRCF
— Abhimanyu Yadav (@WorldlyReviewer) September 26, 2026
Tesla first launched rides in the Cybercab in early September, although the Robotaxi fleet has been active for over a year, as rides began last Summer. Cybercab is truly Tesla’s most crucial vehicle release yet, as it is the first car any company has built that is geared toward full-fledged and end-to-end autonomy, never needing human intervention for anything.
Only available in Austin at the current time, Cybercab has two seats and has been spotted testing around various U.S. states and regions; Tesla plans to deploy the Cybercab in various U.S. cities in the coming months as a best-case scenario.
Tesla Cybercab gets initial tie-in to localized, in-house cathode plant
The availability of the Cybercab has doubled from just 58 units last Monday to 125 the following Friday. Marking a substantial increase in Cybercab availability, the additional ride-sharing units are more than welcome, as wait times for Cybercabs, especially, were quite high.
The dramatic increase is a sign that demand for Robotaxi is growing and Tesla is feeling more confident that its driverless ride-hailing suite, especially its Full Self-Driving software, is able to handle any traffic situation without explicit direction or supervision from a human being.
Tesla Roadster event gets delayed due to unfavorable weather
SpaceX turned a heralding moment for Starship into its greatest
