The US Food & Drug Administration has been questioned on why it did not inspect Elon Musk’s Neuralink before allowing the brain implant company to test its device on humans.
Reuters reported last month that FDA inspectors found problems with record-keeping and quality controls for animal experiments at Neuralink last June, less than a month after the start-up said it was cleared to test its brain implants in humans.
The company, which first tested its device in monkeys and other animals, makes a brain-chip that enables paralysed patients to control a computer using only their thoughts, and is now testing the device in humans.
In a letter to the FDA last week, Democratic representative Earl Blumenauer said he was concerned the agency ignored “troubling evidence” of animal testing violations that had been raised, dating back to at least 2019.
“These alleged failures to follow standard operating procedures potentially endangered animal welfare and compromised data collection for human trials,” wrote Blumenauer, who is involved in health policy.
In response to queries from Reuters about the letter, the FDA said it would respond to the lawmaker directly. It added that it routinely carries out inspections after a human trial is approved. When it inspected Neuralink, the FDA said it did not find violations that would undermine the safety of the trial.
Neuralink did not immediately respond to questions.
In recent years, several device companies have begun testing such brain implants in humans, including Synchron and Blackrock Neurotech, which have both demonstrated the ability of patients to control certain actions with their thoughts.
Two weeks ago, Neuralink presented a livestream on Musk’s X, showing how the first patient implanted with its brain device was able to play online chess using his mind.
Noland Arbaugh, a 29-year-old who was paralysed below the shoulders after a diving accident, also posted a comment by relaying his thoughts.
See more from MedicalBrief archives:
Neuralink’s first human patient controls computer mouse via thought
Step forward in human studies for Neuralink brain implants