U.S. Representative Earl Blumenauer, known for his involvement in health policy, has raised concerns regarding the FDA’s oversight of Elon Musk’s Neuralink.
The lawmaker questioned why the FDA did not inspect the brain implant company before allowing it to conduct human trials.
Blumenauer’s inquiry stems from a report by Reuters revealing FDA inspectors’ findings of record-keeping and quality control issues at Neuralink’s facilities.
These findings occurred shortly after the startup obtained clearance to test its brain implants in humans. The concerns were related to animal experiments conducted by the company.
Neuralink, recognized for its brain-chip technology, has progressed from animal testing to human trials. The company’s innovation allows paralyzed individuals to operate computers using their thoughts, marking a significant advancement in medical technology.
In his letter to the FDA, Blumenauer referenced reports dating back to 2019, highlighting evidence of animal testing violations at Neuralink.
He emphasized the importance of addressing these concerns, particularly in light of reports detailing employees’ complaints about rushed experiments and compromised data quality.
The FDA responded to Reuters, stating its intention to address Blumenauer’s inquiries directly.
The agency asserted its commitment to conducting inspections post-approval, aiming to ensure the safety of human trials. Despite previous concerns, the FDA found no violations undermining the trial’s safety during its inspection of Neuralink.
Notably, Neuralink’s live stream on X, Musk’s social media platform, showcased a paralyzed patient successfully playing online chess using the brain implant.
This demonstration underscores the potential of such technology to improve the lives of individuals with disabilities despite regulatory scrutiny.
In January, Elon Musk, the co-founder of Neuralink, announced a milestone achievement for the brain implant technology firm. The first human implant by Neuralink has been successfully executed.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo via Wikimedia Commons
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