Brain-computer interface company Neuralink announced on 25 May that it has received approval from the US Food and Drug Administration (FDA) for a clinical study in humans. Neuralink made the announcement on Twitter: "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study." The tweet said that the approval "represents an important first step that will one day allow our technology to help many people". The firm also said that the recruitment is not yet open for the trial, and it has yet to give any further details about what the trial will entail. Neuralink was formed in 2016 by Elon Musk and a group of scientists and engineers with the ultimate aim of making devices that interface with the human brain – both reading information from neurons as well as feeding information directly back into the brain.
Neuralink has announced that the U.S. Food and Drug Administration (FDA) has approved the launch of its first clinical study in humans. "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study!" Neuralink's official Twitter account wrote on Thursday.(opens in a new tab) "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." The neurotechnology company isn't recruiting test subjects just yet, and hasn't released any information on exactly what the clinical trial will involve. Even so, fans of Neuralink founder Elon Musk are already chomping(opens in a new tab) at(opens in a new tab) the(opens in a new tab) bit(opens in a new tab) to implant questionable experimental technology in their grey matter. Neuralink aims to develop implantable devices that will let people control computers with their brain, as well as restore vision or mobility to people with disabilities.
Neuralink Corp., Elon Musk's brain-implant company, said it received approval from the US Food and Drug Administration to conduct human clinical trials. "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," the company said Thursday in a tweet. The FDA and Neuralink did not immediately respond to requests for comment. Musk's startup is developing a small device that will link the brain to a computer, consisting of electrode-laced wires. Placing the device requires drilling into the skull. The approval "is really a big deal," said Cristin Welle, a former FDA official and an associate professor of neurosurgery and physiology at the University of Colorado.
United States regulators have given approval for Elon Musk's start-up Neuralink to test its brain implants on people. Neuralink said on Thursday that it received clearance from the US Food and Drug Administration (FDA) for the first human clinical study of implants which are intended to let the brain interface directly with computers. "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study," Neuralink said in a post on Twitter – which is owned by Musk. Neuralink prototypes, which are the size of a coin, have so far been implanted in the skulls of monkeys, demonstrations by the startup showed. With the help of a surgical robot, a piece of the skull is replaced with a Neuralink disk, and its wispy wires are strategically inserted into the brain, an early demonstration showed.
Neuralink, Elon Musk's brain-implant company, said on Thursday it had received a green light from the US Food and Drug Administration (FDA) to kickstart its first in-human clinical study, a critical milestone after earlier struggles to gain approval. Musk has predicted on at least four occasions since 2019 that his medical device company would begin human trials for a brain implant to treat severe conditions such as paralysis and blindness. Yet the company, founded in 2016, only sought FDA approval in early 2022 – and the agency rejected the application, seven current and former employees told Reuters in March. The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees. Major issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain and the challenge of safely extracting the device without damaging brain tissue.
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.
Should artificial intelligence or machine learning (AI/ML) be allowed to alter FDA approved software in medical devices? If so, where should the guardrails be set? The discussions and debates surrounding AI/ML are heated; some believe the technology may destroy humanity, while others look forward to the speed of advancement it will allow. The FDA is getting out ahead on this debate. This week the agency drafted a list of “guiding principles” intended to begin developing best practices for machine learning within medical devices. A new framework envisioned by the FDA includes a “predetermined change control plan” in premarket submissions. This plan would include the types of anticipated modifications, referred to as “Software as a Medical Device Pre-Specifications”. The associated methodology used to implement those changes in a measured and controlled approach that manages risk the FDA calls the “Algorithm Change Protocol.”
The Food and Drug Administration announced the availability of draft guidance that provides recommendations on lifecycle controls in submissions to market machine learning-enabled device software functions. In the "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning-Enabled Device Software Functions," the FDA proposes to ensure that AI/ML-enabled devices "can be safely, effectively and rapidly modified, updated, and improved in response to new data," said Brendan O'Leary, deputy director of the Digital Health Center of Excellence in the FDA's Center for Devices and Radiological Health, in a March 30 announcement. FDA says that companies must also describe how information about modifications will be clearly communicated to users in the PCCP. The agency explains that control plans are not just intended for the AI/ML-enabled software as a medical device – "but for all AI/ML-enabled device software functions." "The approach FDA is proposing in this draft guidance would ensure that important performance considerations, including with respect to race, ethnicity, disease severity, gender, age and geographical considerations, are addressed in the ongoing development, validation, implementation and monitoring of AI/ML-enabled devices," he said.
A new draft guidance by the US Food and Drug Administration (FDA) would allow developers of artificial intelligence (AI) and machine learning (ML) digital health solutions to make changes to their products without submitting a new application. The plan would let submissions include predetermined change control plans (PCCP) that would lay out how developers would ensure changes are safe and effective. According to Ferdous Al-Farique, "While the agency has already allowed more than 500 AI/ML products on the market, many of which already allow PCCP, Congress passed legislation as part of the 2023 Consolidated Appropriations Act that gave FDA explicit authority to approve PCCPs as part of AI/ML product applications." To read more, click here.