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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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NASA taps SpaceX for more astronaut missions as Boeing Starliner remains grounded

NASA just gave SpaceX a $946 million contract for three more astronaut missions through 2030.

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NASA has awarded SpaceX a $946 million contract modification covering three more astronaut missions to the International Space Station, according to an announcement the agency published Friday. The award adds Crew-15, Crew-16, and Crew-17 to SpaceX’s existing Commercial Crew Transportation Capability contract, bringing the agreement’s total value to $5.92 billion across 17 flights.

SpaceX confirmed the award on X, writing that it was excited for Falcon 9 and Dragon to launch NASA’s Crew-15, 16, and 17 missions to the Space Station from Florida. The new missions cover ground, launch, in orbit, and return operations, along with cargo transport and a lifeboat capability while docked at the station, and the period of performance runs through 2030.

The award follows a notice of intent NASA issued in May, when the agency first signaled it would purchase up to six additional post certification missions from SpaceX. Teslarati covered that filing at the time, noting NASA cited technical issues and schedule delays encountered by Boeing as a driving factor. Friday’s contract modification locks in three of those six missions, with the remaining three left open for NASA to award later, potentially to Boeing if Starliner clears certification.

Boeing’s CST-100 Starliner has still not flown an operational crew rotation mission for NASA. The spacecraft’s most recent crewed test flight in 2024 ended without the astronauts returning aboard Starliner, and the company has spent the time since working through thruster problems. SpaceX President Gwynne Shotwell said this week that SpaceX is not retiring Crew Dragon today, for sure, while stopping short of committing to fly it past 2030.

Crew-12 is currently docked at the space station, and NASA has said Crew-13 is targeting a launch in the coming weeks. The newly awarded Crew-15 through Crew-17 missions extend SpaceX’s role as NASA’s primary way of getting astronauts to and from orbit well into the back half of the decade, regardless of what happens with Starliner or Starship in the meantime.

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Investor's Corner

New drone video shows Tesla’s Optimus Factory reaching a turning point

New drone footage shows Tesla’s dedicated Optimus factory steel frame nearing completion at Giga Texas.

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Tesla’s dedicated Optimus factory at Gigafactory Texas is closing in on a finished steel frame, according to drone footage posted Thursday afternoon by longtime site observer Joe Tegtmeyer. In the video, Tegtmeyer said structural steel assembly is now about five column grids away from reaching the building’s north perimeter beam, putting the primary skeleton in its final stretch roughly six months after Tesla broke ground on the North Campus site in late March.

Tegtmeyer’s footage shows concrete already going in on three upper floors while crews continue laying rebar and pouring grade beam footings at ground level. That kind of parallel work, steel rising at one end of the site while concrete sets at the other, is a scheduling approach Tesla used at the original Giga Texas building and appears to be repeating here to save time before the plant’s targeted 2027 production start.

Teslarati has tracked the building’s progress since Tesla confirmed construction was officially underway in May, when the first steel structure went up on what was then bare, reclaimed land. The facility is part of a more than 5.2 million square foot expansion of Giga Texas’s North Campus that Tesla has said will eventually run nearly the length of the existing vehicle factory, over 4,000 feet, while sitting somewhat narrower. Musk has pegged the long term output target at 10 million Optimus units a year once the line is running at full capacity, a volume that would dwarf the one million unit pilot line Tesla is standing up separately at its Fremont, California factory.

Tesla Giga Texas to feature massive Optimus V4 production line

The Texas facility sits alongside another major buildout on the same campus. Terafab, the joint Tesla and SpaceX chip fabrication plant that will eventually supply the silicon running Optimus units in the field. Housing robot assembly and chip production on the same grounds is a deliberate supply chain decision, cutting down on the shipping and lead time that would otherwise sit between the two.

Tesla has not given an updated timeline beyond its previously stated goal of bringing high volume Optimus production online at the site in the summer of 2027. Fremont’s smaller pilot line began mass producing the current Gen 3 robot in January, with that plant expected to build tens of thousands of units this year primarily to generate the real world data Tesla needs to refine the robot’s software before Giga Texas ramps up. Six months of visible construction progress, tracked almost entirely through Tegtmeyer’s recurring drone flights, gives the clearest outside look yet at how seriously Tesla is treating that 2027 deadline.

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Tesla and SpaceX take “Terafab” Trademark fight to Federal Court

Tesla and SpaceX sue a small Illinois firm after cease and desist letters over Terafab.

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SpaceX Terafab rendering

Tesla and SpaceX are asking a federal judge to rule that their planned Terafab chip factory does not infringe a small Illinois company’s trademark, a request that arrives only after months of quiet negotiation broke down this summer.

The dispute traces to May 18, when Tesla filed three U.S. trademark applications for “Terafab” and “Tesla Terafab,” covering semiconductor chips and related chip making services. TERA-print LLC, a nanotechnology company that has held a federal trademark for “Tera-Fab” since 2021, responded five days later with a cease and desist letter. According to the lawsuit, first reported by Reuters, TERA-print argued that Tesla and SpaceX’s use of “Terafab” would confuse consumers familiar with its own trademark, which covers a desktop photolithography printer sold to researchers for sensor and bioengineering work.

What stands out in the filing is the timing of TERA-print’s own paperwork. One day before sending that cease and desist letter, on May 22, TERA-print applied to expand its existing registration to cover semiconductor materials, silicon chips, nanoelectronic devices and AI design services, categories it had not previously claimed. Tesla and SpaceX call that filing opportunistic in their complaint, noting it arrived two months after Tesla’s public Terafab announcement and just days after Tesla’s own trademark applications went in.

Elon Musk launches TERAFAB: The $25B Tesla-SpaceXAI chip factory that will rewire the AI industry

By June 10, TERA-print was threatening to sue for federal trademark infringement, false designation of origin and unfair competition, the complaint states. Rather than wait to be sued, Tesla, SpaceX and SpaceXAI met with TERA-print six separate times between June and August trying to resolve the dispute directly. Those talks collapsed, and the companies filed for declaratory judgment this week in the U.S. District Court for the Western District of Texas, asking a judge to find that “Terafab” does not infringe TERA-print’s mark before TERA-print can file a claim of its own.

TERA-print isn’t backing down. The company told PCMag it discussed a settlement with Tesla as recently as September 2 and feels misled by what it called Tesla’s professed interest in settling. Its CTO, Andrey Ivankin, said TERA-print holds a Defense Department contract to fabricate semiconductors and partially owns Mattiq Inc., an AI company built on TERA-print’s products, and that the company will vigorously defend its rights.

Tesla and SpaceX argue the overlap is superficial. Terafab is planned as a $16.8 billion complex spanning roughly 100 million square feet at the Grimes County site SpaceX confirmed last month, built to produce chips for Optimus robots, Tesla’s AI computing needs and SpaceX’s orbital data center ambitions, a scale and purpose the companies say no reasonable consumer would confuse with a tabletop lab printer. TERA-print’s product line has stayed focused on lithography tools for biological and sensor research since it registered its mark in 2021.

The trademark fight is the second legal dispute tied to the Terafab project in the past week, following a separate SpaceX suit aimed at keeping company records about the facility out of public view, as KBTX reported. Whether construction proceeds under the Terafab name now depends on a federal judge in Austin.

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