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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.

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(Credit: Neuralink/YouTube)

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.

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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.

Maria--aka "M"-- is an experienced writer and book editor. She's written about several topics including health, tech, and politics. As a book editor, she's worked with authors who write Sci-Fi, Romance, and Dark Fantasy. M loves hearing from TESLARATI readers. If you have any tips or article ideas, contact her at maria@teslarati.com or via X, @Writer_01001101.

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Tesla trims Model Y offerings as All-Wheel-Drive gets the axe

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Credit: Tesla

Tesla has trimmed its Model Y offerings as its Standard All-Wheel-Drive configuration has been removed from the online configurator after roughly nine months on sale. The move follows the removal of the Cybertruck, as its trims have also been minimized as that vehicle heads for total discontinuation at the end of Summer 2027.

Launched in February 2026 as a mid-tier dual-motor option between the Rear-Wheel-Drive model and the Premium trims, the Standard All-Wheel-Drive Model Y offered 294 miles of range and a 4.6-second 0-60 mph time in a stripped-down package.

With it gone, the cheapest new AWD Model Y buyers can configure is now the Premium AWD at $49,990, with estimated deliveries pushed into January–March 2027. The $39,990 rear-wheel-drive Model Y remains available for custom orders, and some AWD units are still listed in inventory.

The move arrives days after Tesla sharply narrowed its Cybertruck lineup. New orders for the Dual Motor AWD and Premium AWD versions have been disabled, leaving only the high-performance Cyberbeast—priced around $109,990 before fees—as the sole configurable option.

Elon Musk has stated that Cybertruck production at Gigafactory Texas will wind down around the middle to late summer of 2027 to free manufacturing space for greater Cybercab output. Tesla has raised prices on remaining trims and is prioritizing higher-margin builds while working through an existing order backlog that exceeds what the line can complete before conversion.

These parallel decisions reflect a broader effort to simplify Tesla’s retail customer lineup. Lower-volume or lower-margin variants are being phased out or deprioritized in favor of core, higher-spec models that generate stronger profitability and clearer production planning.

For the Model Y, this concentrates volume on the remaining RWD and Premium configurations while Premium deliveries already stretch into 2027. For the Cybertruck, it accelerates the transition away from a stainless-steel pickup that underperformed relative to initial volume expectations.

Tesla Model Y Standard Full Review: Is it worth the lower price?

The freed capacity and reduced complexity directly support Cybercab scaling. Tesla began pilot Cybercab production at Giga Texas in early 2026, launched paid autonomous rides in Austin in September, and is preparing for substantial volume growth.

By streamlining the existing vehicle portfolio, the company is reallocating factory space, engineering attention, and supply-chain resources toward its purpose-built Robotaxi, which lacks a steering wheel or pedals and is designed exclusively for unsupervised autonomy.

The result is a leaner retail lineup today and a clearer path to high-volume Cybercab deployment tomorrow.

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SpaceX Starship is going for a catch that could change spaceflight forever

SpaceX will try to catch both Starship stages today, a first for any orbital rocket.

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SpaceX is set to launch Starship Flight 15 from Starbase on Friday afternoon, and if both stages make it back to the tower, the mission will go down as the first time an orbital rocket has ever been fully recovered. The 75 minute launch window opens at 4:45 p.m. CT from Pad 2, a day after SpaceX rolled Ship 42 out to the pad and shared photos of the move on X.

The first catch comes quickly. About six and a half minutes after liftoff, Booster 22 is scheduled to fly back to Starbase and settle into the launch tower’s chopstick arms, the first catch attempt for SpaceX’s V3 Super Heavy. SpaceX has caught the booster three times before most recently in March 2025.

The second catch is the one that has never been done. Ship 42 will climb to an orbit about 275 kilometers up, deploy 26 Starlink V3 satellites and complete about 14 orbits. Three of those satellites carry cameras to inspect the ship’s heat shield before it commits to coming home. If its reentry, landing burn and tower approach systems pass their checks, the ship will fire its engines to leave orbit, fall through the atmosphere in its belly flop position, flip vertical and drop into the tower about 22 and a half hours after launch, on Saturday afternoon. SpaceX gave a preview of that maneuver in an animation during its third quarter earnings webcast.

Elon Musk described a successful double catch on that call as “the first time that an orbital launch vehicle has been fully recovered” and a “profound technology milestone,” putting the odds of catching the ship at “more likely than not.” SpaceX has called it a potential “breakthrough moment in making Starship a reliable, rapidly reusable rocket,”

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Reuse is where the economics change. Falcon 9 lands its boosters routinely, but its upper stage is thrown away on every flight. Starship is designed so both stages can be refueled and flown again, which is key to cutting launch costs. That matters for Starlink, where each V3 satellite is expected to carry roughly 10 times the download capacity of the V2 Mini satellites flying today, and for Starmind, SpaceX’s planned constellation of AI compute satellites.

It matters for NASA too. Starship is the lunar lander for the Artemis program, and reaching the Moon requires refilling a ship in orbit using several tanker flights. That plan only works if Starships can fly again and again. Musk has said he expects Starship to reach a weekly launch cadence in the first half of 2027.

Investors are paying attention. Morgan Stanley’s Adam Jonas wrote this week that a catch of both stages would likely be “a material positive” for SpaceX stock.

The last Starship flight in September reached orbit for the first time but ended after about three hours with a splashdown in the Pacific, short of its planned 10 hours, after some engines shut down. Since then, Booster 22 has completed a full 33 engine static fire and Ship 42 a six engine firing, as Teslarati previously reported. As of Friday morning, SpaceX was still waiting on the FAA to approve a license change covering the ship’s return over land.

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Tesla and SpaceX merger talks hit a new stage, and one hurdle remains

Tesla and SpaceX merger talks are reportedly advancing, and a deal could arrive by December.

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Tesla and SpaceX are moving closer to a combination, with a deal announcement possible as soon as December, Bloomberg reported on Thursday, citing people familiar with the matter. The companies have also discussed a scenario in which the announcement slips into early 2027.

Boards and advisers on both sides are now working through the terms of the deal and the governance structure of the combined company, according to the report. One open item is how many SpaceX shares Tesla investors would receive. Bloomberg had previously reported that the two companies were aiming to announce a deal in the first half of next year and close it before the end of President Donald Trump’s term, so a December announcement would pull that schedule forward by months.

Tesla shares rose as much as 1.9% to $398.35 after the report, while SpaceX gained 0.6% to $140.63. SpaceX carries a market value of about $1.9 trillion following its June IPO, and Tesla is valued at about $1.55 trillion, which would make a combination the largest corporate deal on record. Neither company responded to requests for comment.

The talks became official on October 20, when Elon Musk said on SpaceX’s third quarter earnings call that both companies had formed special committees of independent directors to study a merger, as Teslarati reported. Musk said he could not take part because he is “a conflicted party” and called the process “an odd kabuki dance.” He also noted that Tesla would need approval from 50 percent of all outstanding shares, a bar the company missed in 2025 when a board declassification proposal won support from only 39.4 percent.

China remains the biggest structural problem. Bloomberg’s sources said the companies still need to work out how to isolate Tesla’s large and profitable manufacturing business in China from SpaceX’s U.S. government and defense contracts. JPMorgan analyst Rajat Gupta described those two factors last month as “key dynamics that are at odds with each other” for regulatory and shareholder approval. Musk has repeatedly said Tesla has no plans to separate its China business, a position he restated in August after ARK Invest predicted a merger announcement before the end of the year.

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Washington adds another layer. Democrats took control of Congress in this month’s midterms and have pledged to investigate Musk’s business and political activities, which could bring added scrutiny to a deal involving one of the Pentagon’s most important launch and satellite contractors.

The report also lands three weeks before Tesla’s December 3 annual meeting at Giga Texas. That ballot has only three items, led by the re-election of Musk, board chair Robyn Denholm and JB Straubel, and includes no merger proposal. Any deal announced in December would likely require a separate special meeting for Tesla shareholders to vote on it.

The two companies already share a growing list of projects, including the Terafab semiconductor plant in Texas. Tesla’s next generation Roadster, which uses cold gas thrusters built on SpaceX hardware, turned up on display at SpaceX headquarters last month and has become one of the clearest public examples of that overlap.

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