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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.
A Tesla Semi was involved in a fatal collision on U.S. Highway 50 in Dayton, Nevada, on Sunday, June 28, 2026, marking the first known fatal crash involving the electric Class 8 truck. The incident occurred around 7:20 a.m. at the intersection with Traditions Parkway, approximately 40 miles east of Reno and close to Tesla’s Gigafactory Nevada.
According to the Lyon County Sheriff’s Office and the Nevada State Police Highway Patrol, a semi-truck struck two passenger vehicles stopped at a traffic signal. The truck hit the vehicles from behind. Two people were pronounced dead at the scene, and a third person suffered life-threatening injuries and was flown to a hospital, Forbes reported.
Preliminary statements gathered at the scene by the Lyon County Sheriff’s Office suggested the truck driver may have fallen asleep at the wheel. However, the Nevada Highway Patrol, which is leading the investigation, stated that the official cause has not yet been determined.
Additional information is expected to be released early the following week. The truck was seized for evidence as part of the ongoing probe.
Responders at the scene included deputies from the Lyon County Sheriff’s Office, personnel from the Nevada Highway Patrol, Central Lyon County Fire Department, and the Nevada Department of Transportation. The crash led to the temporary closure of U.S. 50 in both directions.
The Tesla Semi is Tesla’s battery-electric heavy-duty truck, produced at the nearby Gigafactory in Nevada. Authorities initially described the vehicle as a semi-truck; its make was subsequently confirmed through reporting and scene identification; an interesting bit of information here, as the Semi is not yet available publicly and many do not know that Tesla builds electric trucks.
The investigation remains active, with no further official details on contributing factors or vehicle systems released as of early July 2026.
This incident highlights ongoing scrutiny of commercial vehicle safety on Nevada highways, particularly involving fatigue. Law enforcement continues to gather evidence and witness statements.
Tesla has expanded its Robotaxi program to Miami, Florida, marking the third state the autonomous ride-hailing platform has made its way to since launching last Summer.
Tesla announced today that the Robotaxi suite would now officially launch rides in a geofence in Miami:
🚨 Tesla’s “Long Weekend” continues with a HUGE announcement regarding Robotaxi!
It’s now in Miami!
Miami joins Austin, Dallas, Houston, and the Bay Area! https://t.co/ujjYjJT3Im pic.twitter.com/yPe1ZdSQIE
— TESLARATI (@Teslarati) July 3, 2026
The first geofence in Miami covers approximately 10 to 14 square miles. The area appears to be focused on western and central Miami, including Miami International Airport (MIA). It also includes popular routes like SR 826 (Palmetto Expressway), US 41 (Tamiami Trail), and connectors such as SR 968, 953, 959, and 972.
This is Tesla’s initial Miami launch zone, smaller and more targeted than some competitors’ areas (for example, Waymo’s initial rollout was broader in eastern neighborhoods). It prioritizes high-traffic, airport-linked routes before wider expansion.
The expansion is a huge signal for Tesla that it is now operating in Florida, a heavy-traffic state with many tourist areas, including Fort Lauderdale, Palm Beach, and the Boynton area, all of which are coastal and will attract perhaps millions of tourists in any given year.
¿Qué lo que Miami?
Robotaxi now available in Miami pic.twitter.com/P1m283seZU
— Tesla Robotaxi (@robotaxi) July 3, 2026
The Tesla Robotaxi network launched last year on June 22, in Austin, Texas, beginning limited commercial operations in that city. It expanded shortly thereafter into the San Francisco Bay Area of California in late July 2025, marking entry into a second state with service covering key areas such as San Francisco, San Jose, and Berkeley.
Full commercial service was achieved in Austin by November 18, 2025, strengthening its presence within Texas before further growth.
In 2026, the network continued expanding across Texas with the addition of Dallas and Houston on April 18, significantly broadening its footprint in the state. This new launch into Miami marks Tesla entering a new state and bringing active locations to include Austin, Dallas, Houston, San Antonio in Texas, and the Bay Area in California.
These sequential expansions have steadily increased the network’s reach across major metropolitan areas in Texas, California, and Florida, focusing on scaling operations city by city and state by state since the initial Austin debut.
Tesla CEO Elon Musk has tempered expectations for the company’s humanoid robot Optimus, emphasizing that initial production will ramp up slowly despite recent progress on the manufacturing line. In a July 1 reply on X, Musk responded to optimistic community speculation by stating, “No, Optimus production will be extremely slow at first, as everything is new. This is not like making a car.”
No, Optimus production will be extremely slow at first, as everything is new. This is not like making a car.
— Elon Musk (@elonmusk) July 1, 2026
The comment came in response to a post theorizing that Tesla had accelerated Optimus V3 development and might soon unveil an impressive demonstration with multiple units already in meaningful production. Musk’s clarification highlights the fundamental differences between scaling a novel humanoid robot and Tesla’s established automotive operations, which benefit from over a century of refined supply chains, tooling, and processes.
Recent updates show tangible advancement. Musk shared a photo of himself walking the Optimus production line at Fremont, where Tesla is converting former Model S/X manufacturing space. According to Q1 2026 earnings commentary, limited production is slated to begin in late July or August 2026 on this converted line.
Tesla Optimus project fires up as Musk sees production line progress
Musk previously noted that Optimus features roughly 10,000 unique parts, making early output rates “literally impossible to predict” and describing them as “quite slow.” A larger dedicated factory at Giga Texas is under construction, targeting higher-volume production around summer 2027 with long-term annual capacity potentially reaching millions of units.
Some experts point out that pioneering humanoid robotics demands inventing new automation techniques, actuator supply chains, and quality-control standards in real time. Unlike vehicles, where components and assembly methods are mature, every element of Optimus—from dexterous hands to AI-integrated movement—requires fresh engineering solutions. Early units are expected to handle simple factory tasks before expanding to more complex roles.
This cautious approach aligns with Tesla’s history of under-promising and over-delivering on complex technologies. While enthusiasts hoped for rapid deployment, Musk’s message underscores a deliberate strategy: prioritize reliability and iterative improvement over rushed volume.
Analysts suggest the S-curve ramp typical of new manufacturing will eventually accelerate once foundational issues are resolved, positioning Optimus as a potential trillion-dollar product line.
Musk has long envisioned Optimus transforming labor markets, assisting in homes, factories, and hazardous environments. By setting realistic timelines, Tesla aims to build sustainable momentum rather than risk disappointment. As the Fremont line comes online this summer, investors and fans will watch closely for the first production metrics and capability demonstrations.
Tesla Semi involved in first known fatal crash in Nevada
Tesla expands Robotaxi to Florida, marking its third state for autonomy
