Neuralink receives FDA clearance to begin human trials of its brain-computer interface (Updated)

Turns out Elon Musk’s FDA prediction was only off by about a month. After reportedly denying the company’s overtures in March, the FDA approved Neuralink’s application to begin human trials of its prototype Link brain-computer interface (BCI) on Thursday. 

Founded in 2016, Neuralink aims to commercialize BCIs in wide-ranging medical and therapeutic applications — from stroke and spinal cord injury (SCI) rehabilitation, to neural prosthetic controls, to the capacity “to rewind memories or download them into robots,” Neuralink CEO Elon Musk promised in 2020. BCIs essentially translate the analog electrical impulses of your brain (monitoring it using hair-thin electrodes delicately threaded into that grey matter) into the digital 1’s and 0’s that computers understand. Since that BCI needs to be surgically installed in a patient’s noggin, the FDA — which regulates such technologies — requires that companies conduct rigorous safety testing before giving its approval for commercial use. 

In March, the FDA rejected Neuralink’s application to begin human trials reportedly in part due to all the test animals that kept dying after having the prototype BCI implanted. According to internal documents acquired by Reuters in December, more than 1,500 animals had been killed in the development of the Neuralink BCI since 2018. The US Department of Agriculture’s (USDA) Inspector General has since launched an investigation into those allegations.  

The FDA’s reticence was also born from concerns about the design and function of the interface when implanted in humans. “The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue,” current and former Neuralink employees told Reuters in March.

While Neuralink has obtained FDA approval to begin its study, the company is not yet seeking volunteers. This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” Neuralink Tweeted on Thursday. “Recruitment is not yet open for our clinical trial.”  

Update, 05/26/23, 11:28 AM ET: This story has been updated to include a response from Physicians Committee for Responsible Medicine, the animal welfare advocacy group that previously uncovered Neuralink’s animal deaths.

On May 25, 2023, Elon Musk’s brain-computer interface company Neuralink shared via Twitter that it had received approval from the FDA to begin human clinical trials. It is important to remember that such FDA approval is not an acquittal of Neuralink’s well-documented track record of animal cruelty and sloppy scientific studies. The approval is also not a guarantee that a Neuralink device will someday be commercially available as a significant number of medical devices that begin clinical trials never reach the market. In addition, Neuralink will likely continue to conduct experiments on monkeys, pigs, and other animals even after clinical trials have begun. Past animal experiments revealed serious safety concerns stemming from the product’s invasiveness and rushed, sloppy actions by company employees. As such, the public should continue to be skeptical of the safety and functionality of any device produced by Neuralink.

The Physicians Committee continues to urge Elon Musk and Neuralink to shift to developing a noninvasive brain-computer interface. Researchers elsewhere have already made progress to improve patient health using such noninvasive methods, which do not come with the risk of surgical complications, infections, or additional operations to repair malfunctioning implants. Noninvasive devices are already demonstrating the ability to improve quality of life for older adults and elderly patients, translate brain activity into intelligible speech, and assist paralyzed patients.

This article originally appeared on Engadget at

Google’s latest AI tackles long and costly drug discovery

It can cost billions of dollars to develop drugs and a large percentage fail at the trial stage, so a number of companies are deploying AI to help in that area. Google’s Cloud division is the latest to join that race with two new suites aimed at addressing drug discovery while advancing precision medicine, it announced

The Target and Lead Identification Suite aims to help drug companies better understand proteins and amino acids that are key to drug development. Specifically, it’s designed to help scientists identify biological targets that researchers can develop treatments around. This could effectively speed up drug discovery and lower costs. 

Early adopters for the suite “include multinational pharmaceutical companies like Pfizer and industry-leading biotech companies including Cereval,” Google Cloud wrote in a press release. “We are partnering with Google on exploring how AlphaFold2 can potentially accelerate our drug discovery process, speeding up our researchers’ ability to conduct their experiments on Google Cloud’s scalable, accelerator-optimized compute platform,” said Pfizer’s principal computational scientist, Nicholas Labello. 

Meanwhile, the Multiomics Suite is designed to tackle genomic data analysis. The idea is to find out how genetic variations affect disease in order to create appropriate and even personalized treatments. Genomic databases tend to be enormous, so the suite would give researchers fast access to the appropriate data, helping accelerate treatments. 

“We would not be anywhere near where we are today” without the tool, Colossal Biosciences CEO Ben Lamm told CNBC. That company has been an early adopter of Multiomics, and Lamm said it would have been a “massive burden” for Colossal to try to build something similar itself. 

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