The Austin-based startup will test its high-bandwidth device to help restore speech in people with extremely limited movement. Brain implant developer Paradromics has received approval from the US Food and Drug Administration to test its device in an early-stage human trial, the company announced Thursday. The Austin-based company is aiming to give a digital voice to people who have lost the ability to speak due to severe motor impairment. The trial will assess the long-term safety of the Paradromics device, as well as its ability to enable synthesized speech and text communication. Paradromics is one of several companies--which include Neuralink, Synchron, Precision Neuroscience, and Cognixion --working on technology to control computers and other devices using brain waves.

While the pace of development of AI has rapidly progressed in recent years, the implementation of safe and effective regulatory frameworks has lagged behind. In particular, the adaptive nature of AI models presents unique challenges to regulators as updating a model can improve its performance but also introduce safety risks. In the US, the Food and Drug Administration (FDA) has been a forerunner in regulating and approving hundreds of AI medical devices. To better understand how AI is updated and its regulatory considerations, we systematically analyze the frequency and nature of updates in FDA-approved AI medical devices. We find that less than 2% of all devices report having been updated by being re-trained on new data. Meanwhile, nearly a quarter of devices report updates in the form of new functionality and marketing claims. As an illustrative case study, we analyze pneumothorax detection models and find that while model performance can degrade by as much as 0.18 AUC when evaluated on new sites, re-training on site-specific data can mitigate this performance drop, recovering up to 0.23 AUC. However, we also observed significant degradation on the original site after re-training using data from new sites, providing insight from one example that challenges the current one-model-fits-all approach to regulatory approvals. Our analysis provides an in-depth look at the current state of FDA-approved AI device updates and insights for future regulatory policies toward model updating and adaptive AI.

A man with Lou Gehrig's disease, also known as ALS, is the 10th person to receive a brain chip that lets him take control of his life using just his mind. Mark, 67, was diagnosed in 2020 and has slowly lost his physical abilities like accessing his phone or feeding himself, but that soon to change after receiving Synchron brain-computer interface (BCI) last August. ALS is a disease that causes nerve cells to deteriorate and results in muscle weakness and reduced dexterity until the person is eventually paralyzed - the entire process can take two to five years, and there is no cure. Mark is now able to send health notifications or pain reports to his provider using just by the BIC reading his brainwaves and translating them into actions carried out on a computer. He will soon be able to use his thoughts for more exciting tasks like turning on Netflix and texting family and friends.

Elon Musk's Neuralink hit the headlines this morning, after the entrepreneur announced that his firm had implanted a chip in the brain of a human for the first time. Having gained FDA approval, Musk announced that a device called'Telepathy' had been implanted and that the unnamed patient was recovering well. But after Neuralink's early trials saw 1,500 animals killed during rushed experiments, experts have raised serious concerned about the implant's safety. Speaking to MailOnline, Dr Dean Burnett, honorary research associate at Cardiff University, called the human trials'disconcerting and alarming.' 'The speed at which [Musk] has gone from having no involvement in neurosurgical implants to making massive global statements is disconcerting and alarming,' he said.

Fox News contributor Dr. Marc Siegel weighs in on how artificial intelligence can change the patient-doctor relationship on'America's Newsroom.' Artificial intelligence-powered ultrasounds are now one step closer to becoming part of routine prenatal care. Sonio Detect, an AI-powered ultrasound scanning technology, has become the first product of its kind to land FDA approval. Made by Sonio, a "femtech" company based in Paris, France, the AI product functions as a high-tech helper for maternity care professionals, scanning for warning signs that could indicate fetal health issues. WHAT IS ARTIFICIAL INTELLIGENCE (AI)?

Elon Musk's SpaceX recently launched the biggest and most powerful rocket into flight, even though it did make it into orbit. But the world's richest man isn't content on expanding his sci-fi inspired technology into just the cosmos. Neuralink, the tech startup co-founded by Musk, also wants to embark on a fantastic voyage into the brain. Two weeks ago, the company announced it had gained approval from the Food and Drug Administration to begin trials to implant brain chips into humans. We don't know when trials will begin, but there's plenty of buzz around Neuralink's development of a brain-computer interface.

Elon Musk's brain-implant company Neuralink last week received regulatory approval to conduct the first clinical trial of its experimental device in humans. But the billionaire executive's bombastic promotion of the technology, his leadership record at other companies and animal welfare concerns relating to Neuralink experiments have raised alarm. "I was surprised," said Laura Cabrera, a neuroethicist at Penn State's Rock Ethics Institute about the decision by the US Food and Drug Administration to let the company go ahead with clinical trials. Musks' erratic leadership at Twitter and his "move fast" techie ethos raise questions about Neuralink's ability to responsibly oversee the development of an invasive medical device capable of reading brain signals, Cabrera argued. "Is he going to see a brain implant device as something that requires not just extra regulation, but also ethical consideration?" she said.

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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.

An advocacy group of more than 17,000 doctors has petitioned the Food and Drug Administration (FDA) to disqualify Elon Musk's Neuralink from receiving approval for its brain implant. The Physicians Committee for Responsible Medicine (PCRM) claims Neuralink has violated the'good laboratory practices' (GLP) regulations, which ensures the quality and integrity of non-clinical laboratory studies, with its'hack job' surgeries and staff'manipulating data.' Some of the animal's deaths were at the hands of Matthew McDougall, the head neurosurgeon, who administered nearly six times the amount of an unapproved'toxic' substance that led to a monkey's death, a former Neuralink employee told DailyMail.com. This was stated in messages written by John Morrison, the study director at the University of California, Davis (UC Davis), Merkley added. Elon Musk said his Neuralink is seeking FDA approval to start human trials, but a group is trying to block these efforts.