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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 has firmly denied recent media reports suggesting that SpaceX has reduced its target valuation for an upcoming initial public offering.
The denial came directly from the SpaceX and Tesla frontman on his social media platform X, where he responded with a single word, “False,” to a post from ZeroHedge that cited Bloomberg sources.
This swift rebuttal underscores Musk’s ongoing effort to manage speculation surrounding one of the most anticipated market debuts in recent history.
False
— Elon Musk (@elonmusk) May 29, 2026
According to the disputed reports, SpaceX had lowered its IPO valuation goal to at least $1.8 trillion from previous ambitions exceeding $2 trillion.
The claims emerged amid growing anticipation for the company’s confidential S-1 filing, which positions it for a potential public listing as early as June.
Some had pointed to strong revenue growth, particularly from the Starlink satellite internet service, which contributed heavily to the firm’s 2025 figures of $18.7 billion. Yet challenges persist in other areas, including substantial investments and losses tied to ambitious projects like Starship development and artificial intelligence initiatives, which plan to make life multiplanetary eventually.
Musk’s response highlights a pattern in which he actively counters what he views as inaccurate portrayals of his companies’ trajectories.
SpaceX, already valued privately at extraordinary levels, stands as a cornerstone of Musk’s empire alongside Tesla and xAI. The entrepreneur has long emphasized the transformative potential of reusable rockets and global broadband access, factors that fuel investor enthusiasm despite operational hurdles.
By rejecting the valuation downgrade narrative, Musk signals confidence in SpaceX’s fundamentals and its readiness for public markets on terms favorable to its long-term vision. People have been waiting a very long time to invest in SpaceX, and the valuation, as well as the introductory share price, is not going to need adjusting.
They’ll have plenty of suitors.
This episode reflects broader dynamics in the technology sector, where rumors often swirl around high-profile entities. Musk’s direct engagement with media narratives serves to maintain transparency and control the narrative around his ventures.
As SpaceX prepares for greater scrutiny in public markets, the founder’s denial reinforces optimism about its prospects. Supporters argue that the company’s innovative edge positions it for enduring success, far beyond short-term valuation debates. With the denial now public, attention turns to forthcoming regulatory filings that could provide clearer insights into SpaceX’s strategy and financial health.
The coming weeks promise to reveal more about how SpaceX will transition into a publicly traded powerhouse.
Tesla’s dreams of operating a fully autonomous ride-hailing platform just took a massive step toward reality, as two separate events have indicated the company is perhaps closer than ever to achieving self-driving as a product.
On Thursday, Tesla was granted authorization by the State of Texas to operate driverless vehicles in a commercial manner. On May 28, Senate Bill 2807, passed by the 89th Texas Legislature, took effect after being passed back on September 1, 2025.
The bill establishes a statewide regulatory framework requiring authorization from the Texas Department of Motor Vehicles for companies to operate automated vehicles commercially on Texas roads.
This covers driverless, or SAE Level 4+, operations for passenger transport, meaning Robotaxi, or freight.
Tesla and other companies can self-certify their vehicles and tech as long as they:
- Operate in compliance with Texas traffic laws
- Maintain proper registration, title, and insurance
- Use compliant automated driving systems
- Record onboard activity and handle system failures and glitches safely.
The new authorization, which was first reported by James Stephenson on X, allows companies to utilize their own processes to determine if their vehicles are ready to operate without drivers.
🚨BREAKING:
Tesla has been authorized by the State of Texas to operate driverless vehicles commercially under the new law that took effect today, May 28th, 2026. Tesla has officially self-certified the software running on its robotaxis as Level 4. $TSLA pic.twitter.com/KSJdsvlaW5— James Stephenson (@ICannot_Enough) May 28, 2026
It is a rule that expedites the entire approval process, keeping agencies out of a usually long, lengthy, and frustrating task that is essential to technological advancements. It essentially means Tesla can launch commercial Robotaxi operations at this point.
On the very same day, Tesla continued the momentum as CEO Elon Musk shared a video of Cybercab units autonomously driving off the property at Gigafactory Texas. This is a major step in the story of the Cybercab.
Mass production of the Cybercab started at Giga Texas in April, and it is already heading out of the factory on its own.
Cybercab driving itself out of the GigaTexas factory pic.twitter.com/EwAMVVDjYy
— Elon Musk (@elonmusk) May 28, 2026
These two major events mark a drastic step forward in Tesla’s progress toward Cybercab and the permissions it needs to operate a self-driving ride-hailing service. Tesla is now able to operate autonomously under Texas law by self-certifying, and with the potentially imminent rollout of Cybercab, Tesla’s autonomous dreams are starting to take serious shape.
Elon Musk
The Tesla and SpaceX merger everyone is talking about is quietly building
Tesla and SpaceX may be closer to merging than Wall Street or either company is admitting.
Elon Musk has reportedly discussed merging Tesla and SpaceX with people close to him, according to CNBC, which cited sources familiar with the conversation. Tesla employees have long expected such a transaction and the topic is openly discussed internally, according to internal sources. With SpaceX is days away from kicking off its Wall Street roadshow for what could be the largest IPO in market history, this would be the first time the company will have public market currency to execute a stock-for-stock deal with Tesla.
The financial logic for a merger would make sense. A combined SpaceX and Tesla would create a conglomerate spanning rockets, satellites, electric vehicles, AI infrastructure, and energy storage valued at roughly $3.35 trillion to $3.6 trillion based on SpaceX’s IPO target range and Tesla’s current market capitalization. The two companies are already more intertwined than most people realize. SpaceX bought $697 million worth of Tesla Megapack systems for xAI data centers and $131 million worth of Cybertrucks. Tesla invested $2 billion in xAI, which subsequently merged with SpaceX. Past transactions also include Tesla selling solar equipment and parts to SpaceX, and SpaceX helping with Cybertruck materials.
Will Tesla join the fold? Predicting a triple merger with SpaceX and xAI
Musk himself signaled where this was heading in November 2025 when he posted on X, “My companies are, surprisingly in some ways, trending towards convergence.” Tesla and SpaceX announced a joint semiconductor fabrication facility in Austin called Terafab on the Gigafactory Texas campus, covering two advanced chip factories, with one serving Tesla’s AI needs for vehicles and Optimus robots, the other targeting space-based data centers under SpaceX’s infrastructure vision.
Wedbush analyst Dan Ives places the probability of a merger at 80% to 90% with a target completion in the first half of 2027. The mechanics of a deal became possible the moment SpaceX filed its S-1. Legal experts said a merger likely would not spark antitrust issues but would raise concerns among shareholders in each company, with questions around which company would be the parent, how a stock swap would take place, and who determines the appropriate price. Musk holds about 20% of Tesla’s equity but controls 85.1% of SpaceX’s voting power through a super-voting share class, meaning he would largely be negotiating the terms with himself.
Not everyone is convinced the timing is imminent. Traders on Kalshi place only 33% odds that a merger will happen before May 2027. The more immediate concern for Tesla shareholders is whether the SpaceX IPO pulls capital and Musk’s attention away from Tesla before any merger consolidates the upside for both.
What is clear is that the structural groundwork is already being laid. The Terafab announcement, the xAI merger, the shared supply chain, the cross-company balance sheet transactions, and now the IPO all point in the same direction. Whether the merger follows in 2027 or later, the two companies are already operating more like divisions of a single entity than independent competitors.
Elon Musk strikes down reports on SpaceX IPO rumors
Tesla’s Robotaxi dreams just took a massive step toward reality
