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☆ US lawmakers ask SEC to scrutinize Musk comments on Neuralink
▼ + stars: | 2023-11-22 | by ( Marisa Taylor | ) www.reuters.com time to read: +3 min

Neuralink logo and Elon Musk photo are seen in this illustration taken, December 19, 2022. Yet Musk, Neuralink's CEO, downplayed investor concerns about the results of its animal testing, the letter said. Musk wrote that "no monkey has died as a result of a Neuralink implant," in a post to his social media site, X, on Sept. 10. Neuralink did not respond to requests for comment on the letter to the SEC. As a result, Musk's statement "may have violated" SEC rules in denying a connection, the lawmakers wrote.

Persons: Elon, Dado Ruvic, Elon Musk, Earl Blumenauer of, Jim McGovern, Barbara Lee, Tony Cardenas, Musk, Neuralink, Marisa Taylor, Michele Gershberg, Marguerita Choy Organizations: REUTERS, U.S, Securities and Exchange Commission, Democratic, Reps, Massachusetts, SEC, Reuters, U.S . Food, Drug Administration, Thomson Locations: Earl Blumenauer of Oregon, Tony Cardenas of California

☆ Listen Now: SpaceX employees say they’re paying the price for Musk’s push to colonize Mars
▼ + stars: | 2023-11-10 | by ( ) www.reuters.com time to read: 1 min

Through interviews and government records, reporter Marisa Taylor documented more than 600 injuries of SpaceX workers since 2014. Employees say they’re paying the price for Elon Musk’s relentless push to colonize Mars at breakneck speed. Listen to Taylor describe her report. Visit the Thomson Reuters Privacy Statement for information on our privacy and data protection practices. Further ReadingAt SpaceX, worker injuries soar in Elon Musk’s rush to MarsOur Standards: The Thomson Reuters Trust Principles.

Persons: Marisa Taylor, Taylor, Elon Musk’s Organizations: Apple, Google, Reuters, Employees, Elon, Thomson, SpaceX Locations: Elon

☆ Regulator says found no animal welfare breaches at Musk firm beyond 2019 incident
▼ + stars: | 2023-07-19 | by ( Marisa Taylor | ) www.reuters.com time to read: +5 min

July 19 (Reuters) - The head of the U.S. agency responsible for animal welfare has told lawmakers that it did not find any violations of animal research rules at Elon Musk's Neuralink beyond a 2019 incident the brain implant company had already reported. The inspection included visits at Neuralink's two facilities in January 2023, Vilsack wrote, adding that there would be more inspections. Vilsack said in his letter his agency did not include in its inspection citations an "adverse surgical event" at Neuralink that occurred in August 2019. The company proactively reported it and took corrective action, which complied with the policy at the time, Vilsack added. The mistakes weakened the experiments' research value and required the tests to be repeated, leading to more animals being killed.

Persons: Thomas Vilsack, Earl Blumenauer, Vilsack, Musk, Neuralink, Blumenauer, Ryan Merkley, Marisa Taylot, Greg Roumeliotis, Robert Birsel Organizations: U.S, Elon Musk's, Department of Agriculture, Reuters, USDA, Physicians, Responsible Medicine, Neuralink, University of California, UC Davis, Drug Administration, FDA, Department of Transportation, Washington , D.C, Thomson Locations: Neuralink, Davis, Washington ,

Neuralink's valuation jump in secondary trades is in sharp contrast to other startups. About 85% of pre-IPO companies are currently valued in secondary trades at an average discount of 47% to their last funding round, according to data provider Caplight. The maximum amount sought for the Neuralink shares marketed for sale at a $7 billion valuation was just $500,000, according to the email seen by Reuters. Sim Desai, chief executive of Hiive, an online platform where the shares are traded, said demand for Neuralink stock has been "tremendous." Neuralink stock that some of the employees hold has jumped around 150% in value in just two years, based on the secondary trades.

Persons: Elon, Kip Ludwig, Musk, Neuralink, Sim Desai, Arun Sridhar, Sridhar, Galvani, Rachael Levy, Marissa Taylor, Krystal Hu, Greg Roumeliotis, David Gregorio Our Organizations: U.S . National Institutes of Health, Reuters, U.S . Food, GSK Plc, Sciences, FDA, U.S . Department of Agriculture, Department of Transportation, Thomson Locations: Neuralink's, U.S, Washington ,, New York

The membership of the panel at Musk’s company, Neuralink, raises questions about potential violations of conflict-of-interest regulations aimed at protecting research integrity, a dozen animal-research and bioethics experts told Reuters. Autumn Sorrells has chaired an oversight board approving animal experiments by Elon Musk’s brain-chip startup, Neuralink, and also run the company’s animal care program. Reuters couldn’t determine the compensation terms of the Neuralink IACUC members who are also company employees. The independence of such boards, Nicolelis said, is critical to protecting the integrity of animal research that could impact humans in future clinical trials. These institutions generally prohibit people with direct financial interests from serving on IACUCs or voting on animal experiments.

March 27 (Reuters) - Elon Musk's brain implant company Neuralink has approached one of the biggest U.S. neurosurgery centers as a potential clinical trials partner as it prepares to test its devices on humans once regulators allow for it, according to six people familiar with the matter. Barrow has helped standardize brain implant surgeries in which the patient can remain asleep, a key step in making it more acceptable to a broad set of the population, Ponce said. This is in line with Musk's vision for Neuralink's brain chip. The billionaire CEO of Tesla Inc (TSLA.O) and majority owner of Twitter has said Neuralink's brain implants will become as ubiquitous as Lasik eye surgery. Neuralink's implant is a brain computer interface (BCI) device, which uses electrodes that penetrate the brain or sit on its surface to provide direct communication to computers.

☆ Factbox: Neuralink, other brain-chip makers face long road to FDA approval
▼ + stars: | 2023-03-02 | by ( Marisa Taylor | ) www.reuters.com time to read: +2 min

March 2 (Reuters) - Neuralink, founded in 2016, has yet to receive FDA approval to test its brain chip in humans. It received U.S. approval for human testing in July 2021, five years after applying to the U.S. Food and Drug Administration (FDA). NEUROPACENeuroPace (NPCE.O), founded in 1997, didn’t secure FDA approval for its brain implant to treat epilepsy until 2013. BLACKROCK NEUROTECHBlackrock Neurotech, established in 2008, has tested its brain implant in humans for almost two decades. The company had hoped to secure approval to commercialize the implant from the FDA by last year but is still working on it, according to the company.

☆ U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks
▼ + stars: | 2023-03-02 | by ( Rachael Levy | Marisa Taylor | ) www.cnbc.com time to read: +19 min

Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device. "Everybody in the industry was saying: 'Oh my God, they're going to run straight into a brick wall,'" Ludwig said of Musk's bid for FDA approval. For example, NeuroPace, which makes the brain implant to treat epilepsy, received final FDA approval in 2013 – 16 years after the company's launch. Beyond grants, it provides access to government experts who advise on how to gain FDA approval and commercialize a device. Musk's emails to Neuralink staffers often come from his SpaceX address, said two people who reviewed them.

[1/2] People line up at a makeshift fever clinic set up inside a stadium, amid the coronavirus disease (COVID-19) outbreak in Beijing, China December 19, 2022. "We stand ready to help any country in the world with vaccines, treatments, anything else that we can be helpful with," he said. "We want China to get COVID right," Blinken said earlier this month. “China faces a very challenging system in reopening,” Powell said, adding that its manufacturing, exporting and supply chain remain critical. Officials set up health centers and apps that told people with symptoms how to avoid infecting others, he said.

The agency did not respond to requests for comment on its record monitoring animal research experiments nationally. The USDA inspector general has published at least three reports since 2014 critical of the agency’s lax oversight, though its criticism dates back to the 1990s. Neuralink says on its website that it champions animal welfare and tries to reduce animal testing where possible. Two academic studies conducted in 2009 and 2012 found that animal research committees approved between 98% and 99% of experiments proposed by researchers. Envigo was made to sign the consent decree giving up the beagles only after the USDA inspector general and the Justice Department investigated and found evidence of inhumane treatment.

After learning about its Russian roots from Reuters, it removed Pushwoosh software from seven public-facing apps, citing security concerns. The U.S. Army said it had removed an app containing Pushwoosh code in March because of the same concerns. Pushwoosh code has been embedded into almost 8,000 apps in the Google and Apple app stores, according to Appfigures, an app intelligence website. "We haven't found any clear sign of deceptive or malicious intent in Pushwoosh's activity, which certainly doesn't diminish the risk of having app data leaking to Russia," he added. The CDC apps that contained Pushwoosh code included the agency's main app and others set up to share information on a wide range of health concerns.

The U.S. Food and Drug Administration findings come nearly three years after the agency's inspectors began documenting quality-control issues at the same Lilly plant in Branchburg, New Jersey. FDA inspectors returned to the plant this past July, spending 12 days there. Lilly did not directly respond to questions about the FDA inspectors' findings. The FDA report did not say whether the medicines in question were ultimately shipped to customers or discarded. In November 2019, FDA inspectors found that quality-control data had been deleted and not appropriately audited at the New Jersey plant.

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