The US Securities and Exchange Commission (SEC) has opened an investigation into Neuralink, the brain implant company owned by Elon Musk.
The billionaire published a letter from his lawyer Alex Spiro on X confirming the probe, followed by a second post of an AI-generated image depicting the agency’s chairperson Gary Gensler as a snail.
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The letter mainly details how Musk is facing charges on “certain purchases, sales, and disclosures of Twitter Shares”. The Neuralink investigation is also mentioned by Spiro as evidence of an “improperly motivated campaign” against Musk.
A SEC spokesperson told Medical Device Network: “It is the policy of the SEC to conduct investigations on a confidential basis to preserve the integrity of its investigative process. The SEC therefore does not comment on the existence or nonexistence of a possible investigation.”
Neuralink did not immediately respond to a comment request.
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By GlobalDataThe probe by the SEC follows four lawmakers who requested the SEC last year to investigate whether Musk misled investors about the safety of the company’s implant technology, as per a letter seen by Reuters.
However, the latest development in regulatory controversies involving Neuralink comes at a time with higher political stakes on the line. Musk was selected by US President-elect Donald Trump to co-lead a new department, the Department of Government Efficiency (Doge), aimed at cost-cutting and improving government efficiency.
The tech businessman owns X, SpaceX and Tesla alongside Neuralink and is set to have greater influence on Capitol Hill in the new year. Musk is also the wealthiest person in the world, with an estimated wealth of more than $400bn.
Brain-computer interfaces (BCIs) are chips implanted in brain tissue that take brain signals and translate them into commands. The measured signals, which can be described as ‘thoughts’, are relayed to a secondary, external device which then carries out a specific function.
The main application for BCIs is currently in the neuromuscular field – assisting paralysed patients in moving muscles. Neuralink has so far implanted two patients with its first BCI product designed to give paralysed people the ability to control external secondary devices with thoughts. The first implant of the product, now called Telepathy, led to viral videos of the patient playing chess on a computer using only his thoughts, along with posting on social media.
A second spinal cord injury patient was implanted in August this year, with Neuralink saying the participant has been playing video games and started to use 3D design software a month after the surgery. The company also recently revealed it will launch a new feasibility trial studying its brain implant linked with an assistive robotic arm.
Although Neuralink has made headlines for its cutting-edge technology, the company has also had its fair share of controversy. According to an investigation by Reuters, Neuralink is estimated to have killed 1,500 animals, including more than 280 sheep, pigs, and monkeys, following experiments since 2018. Sources say the number of animal deaths is higher than it should be, and the company is currently under federal investigation by the US Department of Agriculture (USDA).
Reports of animal testing being rushed, causing needless suffering and deaths, means the company may have violated the Animal Welfare Act. In a July 2023 update to the ongoing investigation, the USDA confirmed one incident in 2019 – involving the death of a male rhesus monkey – was not recorded as a violation of the law due to a now-rescinded policy.
The US Food and Drug Administration (FDA) issued recommendations in 2021 for both nonclinical and clinical testing of BCI devices as their promise in restoring motor capabilities in paralysis patients grows. Other companies in the BCI space that are at the clinical trial stage include Clinatec, BrainGate, and Synchron. Experts told Medical Device Network earlier this year that BCIs could reach the market in around five to eight years.
