Elon Musk’s brain-implant company Neuralink on Thursday said the US Food and Drug Administration (FDA) had given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval.

The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.

Neuralink and the FDA did not immediately respond to Reuters requests for comment.

Musk envisions brain implants could cure a range of conditions including obesity, autism, depression, and schizophrenia as well as enabling web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices’ safety that he would be willing to implant them in his children.

On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employees told Reuters in March.

The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees. Major issues involved the lithium battery of the device, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.

Neuralink, founded in 2016, has been the subject of several federal probes.

In May, US lawmakers urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.

The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.

Neuralink is also under investigation by the US Department of Agriculture’s Office of Inspector General for potential animal-welfare violations. This probe has also been looking at the USDA’s oversight of Neuralink.

Neuralink has not responded to requests for comment on the probes.  

© Thomson Reuters 2023

A team led by Jeff Bezos’ space company Blue Origin won a coveted NASA contract to build a spacecraft that will send astronauts to and from the moon‘s surface, NASA’s chief announced on Friday, capping a high-stakes contest.

NASA’s decision will give the agency a second ride to the moon under its Artemis program, after it awarded Elon Musk‘s SpaceX $3 billion (nearly Rs. 24,850 crore) in 2021 to land astronauts on the moon for the first time since the final Apollo mission in 1972.

Those initial missions using SpaceX’s Starship system are slated for later this decade.

The Blue Origin contract is valued roughly $3.4 billion (nearly Rs. 28,150 crore), NASA’s exploration chief Jim Free said, with Blue Origin privately contributing “well north” of that amount, Blue Origin’s lunar lander head John Couluris said.

“Honored to be on this journey with @NASA to land astronauts on the Moon — this time to stay,” Amazon.com billionaire founder Bezos said in a tweet after the announcement.

Blue Origin plans to build its 52-foot (16-meter) tall Blue Moon lander in a partnership with Lockheed Martin, Boeing, spacecraft software firm Draper, and robotics firm Astrobotic.

SpaceX’s Starship lander is poised to conduct the first two astronaut moon landings under NASA’s Artemis program, sending a pair of astronauts to the lunar surface for each mission. The Blue Moon landing, planned for 2029, is also expected to ferry two astronauts to the surface.

“Our partnership will only add to this golden age of human spaceflight,” NASA administrator Bill Nelson said. He added that having a second moon lander for the agency’s Artemis mission promotes commercial competition, echoing a trend in recent years that reduces costs for NASA.

Friday’s announcement in Washington was a long-awaited outcome for Blue Origin, which had unsuccessfully had competed for past contracts. The space company overcame a rival bid from Leidos-owned defense contractor Dynetics Inc, the head of a partnership with Northrop Grumman.

Those companies lost out to SpaceX for the 2021 contract, part of an initial moon lander procurement program. NASA under that program said it could pick up to two companies, but blamed budget constraints for only going with SpaceX.

This new contract is a boost for Bezos, who since founding Blue Origin in 2000 has invested billions into the company to compete for high-profile commercial and government space contracts with SpaceX, a dominant force in satellite launches and human spaceflight.

After losing in 2021, Blue Origin unsuccessfully fought to overturn NASA’s decision to ignore its Blue Moon lander, first with a watchdog agency and then in court.

Blue Origin and lawmakers had pressured NASA to award a second lunar lander contract to promote commercial competition and ensure the agency has a backup ride to the moon. NASA in early 2022 announced the program for a second lander contract.

Couluris, who will lead Blue Origin’s development of the moon lander, said Friday’s award was hard fought outcome.

“We’ve been working for some time, and we’re still ready to go,” he said.

© Thomson Reuters 2023 

US lawmakers will ask regulators to investigate whether the make-up of a panel overseeing animal testing at Elon Musk‘s brain-chip startup Neuralink contributed to botched and rushed experiments.

US House Representatives Earl Francis Blumenauer and Adam Schiff, both Democrats, have signed a draft letter to the US Department of Agriculture (USDA) requesting a probe into how Neuralink oversaw its experiments, Blumenauer’s office said.

The lawmakers have shared the draft with peers to gather more signatures and plan to send it to the USDA on Monday. The draft states that they are responding to a May 4 Reuters story which revealed that Neuralink filled its oversight board with company employees who stand to benefit financially from the start-up securing regulatory approval for its novel brain chip.

The panel approved experiments that resulted in the unnecessary deaths and suffering of animals, Reuters showed in a December 5 story. A spokesperson for Blumenauer said the USDA did not respond to an earlier request from lawmakers for a probe into Neuralink in the wake of that story.

“Congress has a significant interest in ensuring that all facilities using animals in research and testing — whether they are government-run, universities, or private companies — comply with the minimal standards of the Animal Welfare Act,” the draft letter states.

Musk and Neuralink representatives, and spokespeople for the USDA and the agency’s inspector general, did not respond to requests for comment.

Neuralink has already been the subject of federal probes. Reuters reported on December 5 that the USDA’s Inspector General was investigating, at the request of a federal prosecutor, potential violations of the Animal Welfare Act, which governs how researchers treat and test certain types of animals. This probe has also been looking at the USDA’s oversight of Neuralink.

The Inspector General and the USDA did not respond to a request for comment on the progress of that investigation.

The US Department of Transportation said in February it was investigating Neuralink over the movement of hazardous pathogens. An agency spokesperson said this probe is continuing, without providing details.

USDA inspectors visited Neuralink’s California and Texas facilities in January in response to Reuters’ reporting and the queries of lawmakers, but found no issues, Reuters reported last week.

Neuralink has been trying to secure clearance to advance to human trials after a prior attempt was rejected last year by the Food and Drug Administration because of safety concerns.

© Thomson Reuters 2023