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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.
Investor's Corner
NASA taps SpaceX to launch the telescope that could unlock new worlds
NASA’s Roman Space Telescope heads to orbit this August aboard SpaceX’s Falcon Heavy with massive scientific ambitions.
SpaceX is set to play a central role in one of NASA’s most anticipated science missions in years. The company’s Falcon Heavy rocket, currently the most powerful operational launch vehicle in the world, will carry the Nancy Grace Roman Space Telescope into orbit on August 30 from Kennedy Space Center in Florida. Roman is now in final preparations inside the Payload Hazardous Servicing Facility, where on June 26 technicians used a crane to lift the observatory into a specialized stand for fueling and pre-launch testing.
Roman is named after Nancy Grace Roman, NASA’s first chief of astronomy, whose career helped shape how the agency approaches space science.
NASA chose SpaceX Falcon Heavy because of Roman’s needs to reach a specific orbit far from Earth, well beyond where a standard Falcon 9 can deliver it. The Falcon Heavy, which first flew in 2018, has since become NASA’s go-to option for missions that need serious muscle without the cost and complexity of older launch systems.
Celebrating SpaceX’s Falcon Heavy Tesla Roadster launch, seven years later (Op-Ed)
Roman will carry a field of view at least 100 times wider than the Hubble Space Telescope, meaning it can photograph enormous swaths of the universe in a single shot rather than the narrow slices Hubble captures. That difference in scale is significant. While Hubble reshaped our understanding of the cosmos over 30 years, Roman is built to work faster and wider, surveying hundreds of millions of galaxies at once.
One of Roman’s most compelling capabilities is its potential to discover and photograph planets orbiting stars outside our solar system, and with enough precision to directly image planets that would otherwise be lost. That means scientists could study the atmosphere and surface characteristics of distant worlds rather than simply confirming they exist. Combined with Roman’s sweeping field of view, the telescope could detect thousands of exoplanets, and some of those planets may be in habitable zones where liquid water could exist. No telescope currently in operation has this level of power and capability. That capability alone could change what we know about other worlds, and perhaps finally answer the question: are we the only intelligent lifeforms in existence?
What Roman actually finds once it reaches orbit is an open question, and that is exactly what makes this launch worth watching.
News
Tesla confirms crucial detail of Miami Robotaxi launch
Tesla has confirmed a crucial detail of its Miami Robotaxi launch, stating that the fleet is operating on an Unsupervised basis, joining a few other cities where company employees do not watch over the vehicles from inside.
Tesla’s Head of AI, Ashok Elluswamy, confirmed the detail on X, answering a highly speculated question about the Robotaxi Service in Miami, which was launched on June 3:
Unsupervised
— Ashok Elluswamy (@aelluswamy) July 3, 2026
The first launch of Robotaxi in Florida, Miami presents a unique opportunity for Tesla as it is operating the Unsupervised Robotaxi ride-hailing service in a major tourist hotspot in the Sunshine State. It also signals the suite will expand to other cities soon; many have requested Orlando, a heavy tourist spot with Disney and other resorts nearby, get access to the program soon as well.
Miami is getting a conservative rollout as well, just as Tesla has done with other cities. The initial geofence covers a compact 10–14 square mile zone in western Miami-Dade County, primarily West Miami extending toward Doral and Sweetwater. It is bounded roughly by SR-826 (Palmetto Expressway) to the north and US-41 (Tamiami Trail) to the south, excluding downtown Miami, Miami Beach, the airport, and most of Coral Gables.
Tesla has also been pretty slim on other details. For example, Tesla has not disclosed the exact fleet size, but field reports and license plate tracking indicate just two unsupervised Model Y vehicles were active on launch day, increasing to three within 48 hours.
According to The Road to Autonomy, a nearby staging lot near Miami International Airport holds dozens of Cybercabs alongside additional Model Y units, suggesting capacity for rapid scaling as demand and data collection grow.
The confirmation of Robotaxi being Unsupervised carries immense weight. It establishes that Tesla’s Miami Robotaxi operations run without human safety drivers or remote supervision, relying entirely on the company’s Full Self-Driving technology. Miami becomes the second major U.S. city after Austin to offer unsupervised Robotaxi rides from day one.
The move reflects rapid progress in Tesla’s AI efforts. Neural networks trained on vast real-world data now handle complex urban environments, including South Florida’s heavy traffic, pedestrians, and rainy conditions. Industry observers see it as validation of Tesla’s vision-centric, data-driven approach versus traditional rule-based systems; a truly unorthodox approach in this day and age.
Challenges remain, including regulatory oversight, public trust, and scaling the fleet to match geofence ambitions. Miami’s small initial footprint and limited vehicles highlight a deliberate, measured expansion strategy focused on safety and data gathering.
Nevertheless, the unsupervised confirmation marks a pivotal milestone. It showcases technical readiness and advances Tesla’s vision of transforming vehicles into autonomous revenue generators while reshaping urban mobility. For Miami users, driverless transportation has moved from concept to reality.
News
Radiologist who drove Tesla off cliff has attempted murder charges dismissed
A California radiologist who drove his Tesla Model Y off a 250-foot cliff in an attempt to kill his family has had his charges dismissed after doctors say he is “doing well” in a mental health program.
Dharmesh Patel was charged with three counts of attempted murder in connection with a January 2023 crash where he drove his Tesla off a cliff, injuring his wife and two children, aged 7 and 4 at the time.
Patel drove the Tesla off Devil’s Slide in California, an area that is extremely rough to the point that investigators and rescuers expected the worst when arriving at the scene for the first time. Patel supposedly had schizoaffective disorder, according to Deputy District Attorney Dominique Davis.
Shockingly, Patel’s wife, who was in the vehicle, testified that she did not want her husband to be prosecuted, noting that their children missed their father and they wanted him to come back home. Patel’s attorney argued, “not everyone who commits a crime is a criminal.”
Doctor who took Tesla off cliff gets support from unlikely person
A three-day trial in Mental Health Diversion Court ruled in Patel’s favor, which kept him out of jail and instead on house arrest. He was admitted to a Mental Health Diversion Program, which he successfully completed, the Associated Press reported. San Mateo County District Attorney Steve Wagstaffe said the judge was “required by law” to dismiss the charges:
“If the person who’s given mental health diversion follows the treatment plan, there’s nothing that can be done, and at the end of the two years he gets it wiped out of his record.”
Wagstaffe said he has argued, along with other DAs in California, to have attempted murder removed from the list of charges eligible to be dismissed due to mental health diversion programs.
Patel had the charges officially dismissed on Monday; his wife waited for him as he left court and they departed the building together, according to Mercury News. Patel surrendered his California medical license in December.
The crash has been one of the best examples of Tesla’s incredible engineering, which has saved four lives in this particular instance. The car was totalled but kept the four human beings alive and safe, which is something that many referred to as “an absolute miracle.”