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Wall Street Journal
17-05-2025
- Health
- Wall Street Journal
Coming to a Brain Near You: A Tiny Computer
A high-stakes technology race is playing out in the human brain. Brain-computer interfaces are already letting people with paralysis control computers and communicate their needs, and will soon enable them to manipulate prosthetic limbs without moving a muscle. The year ahead is pivotal for the companies behind this technology. Fewer than 100 people to date have had brain-computer interfaces permanently installed. In the next 12 months, that number will more than double, provided the companies with new FDA experimental-use approval meet their goals in clinical trials. Apple this week announced its intention to allow these implants to control iPhones and other products. There are dozens of so-called 'neurotech' startups. Four lead the field of implants: Paradromics, Synchron, Precision Neuroscience and Elon Musk's Neuralink, which in some ways is the most ambitious of the four. All but Paradromics have reached the point at which they are putting tech inside people's heads. Each has its own approach, and all offer reasons they believe their product will come out ahead. All four are betting they'll eventually become a standard part of care for tens of thousands, perhaps even millions, of us. The prize they're after: Morgan Stanley projects a $1 billion-a-year brain-computer implant market by 2041. Other than perhaps the quest for human-level artificial intelligence, or colonization of other planets—not coincidentally two other areas where Musk is a big proponent—few fields exhibit such a wide gulf between a technology's potential and its near-term prospects. 'There is a vision that this is going to be a mass-consumer thing, which is a vision that you can sell,' says Dr. Iahn Cajigas, a neurosurgeon at the University of Pennsylvania who has done pioneering research on brain implants, and has installed them in a handful of patients. 'As a clinician, I find that kind of a dangerous way to talk.' These are medical products, he emphasizes, with all the risks that attend brain surgery, including infection. 'To take the risk of a brain implant, if you're a young person with no medical problems, because you're at the mall and you want a better interface with your phone, I don't know how reasonable that is in the current world we live in,' Cajigas added. For the leading companies in the brain-computer interface market, it's generally accepted that the more bandwidth required, the more invasive the implant must be. Future breakthroughs in signal processing aside, implants have to go deeper into our brain tissue to get the best performance. Unknowns about safety, performance and cost are why the trials that happen in the coming year could make or break these four contenders. Synchron, the first to collaborate with Apple, is among the least invasive. Its implant, a tubular mesh of electrodes, is run through a major blood vessel in the brain, like a stent. It can be installed without opening the patient's skull, so more physicians could be trained to perform the operation, says Kurt Haggstrom, the company's chief commercial officer. The downside: The brain-activity readings from the electrodes tend to be less precise. In the Apple scenario, patients must wear Apple's Vision Pro goggles for now. They move a cursor via eye tracking, not mind control, then 'click' an item by thinking about a large movement of one of their limbs. By the end of 2025, Synchron is to begin final FDA trials of its implantable brain-computer interface. Those trials will take about two years, says Haggstrom. Precision Neuroscience aims to put a small, flat array of electrodes onto the surface of people's brains. While the current system is wired, Precision is developing one that is completely wireless, where nothing protrudes through skin and it communicates and recharges wirelessly. With 1,024 electrodes spread across 1.5 square centimeters, the system can potentially do more than Synchron's. For example, it might be able to translate thought to speech. A key challenge: Neuralink and others benefit from decades of deep-brain recordings in primates. Precision records neural activity differently, and researchers are only beginning to map the signals, says Cajigas, who has tested it in 11 patients so far. (He's not a paid Precision collaborator.) 'In the next year, I think this could be a viable solution for patients who are amputees to control a robotic hand,' he adds. With its new FDA permissions, Precision can install its system in a person's head for up to 30 days. The company will be putting its devices in somewhere between dozens and a hundred patients in the next 12 months, says CEO Michael Mager. If those trials are successful, the company will test more permanent implants. Paradromics' brain-computer interface looks like a coin with Velcro on one side, with 421 tiny electrodes that push 1.5 millimeters into the brain. Installing several of these electrode arrays could allow for an especially fast connection, like the difference between a bad Wi-Fi signal and a great one. It can record from individual neurons, like Neuralink's system, says Chief Executive Matt Angle. The company's electrodes are so small, they could in theory go unnoticed by the patient's brain, preventing the kind of scarring and other issues that bedeviled early systems in university labs, he adds. The company hasn't installed one in a human yet, but two have been inside the brains of sheep for three years, and both maintained a strong connection to the brain throughout that time. Paradromics is part of an FDA program designed to accelerate the approval of breakthrough medical devices, and plans to start its first clinical trial in humans later this year. Neuralink has implanted devices in three patients, Musk, its founder, has said. The second patient has shown off capabilities previously demonstrated only in research labs, where wires went deep into participants' brains and ran directly to external computers. With electrodes implanted seven millimeters into the brain, that Neuralink patient could design software, play videogames and more. This kind of implant comes with potential trade-offs, says Cajigas. There's the question of whether, over time, the brain will respond to these electrodes in ways that make them unusable. And then there's the matter of upgradeability: Once you've put electrodes deep into your cortex, it's not clear how easily you'll be able to take them out and put in a new model. Neuralink didn't respond to requests for comment. Getting a brain implant might one day become as routine as, say, getting a cochlear implant, which by 2022 had reached a million hearing-impaired patients. If so, the ability to directly interface with our brains could be one of the most transformative medical, and potentially consumer, technologies in history. Experts I interviewed described various potential uses for brain-computer interfaces: figuring out which medication works best for our particular brain chemistry; using just thoughts to control vehicles, limbs and exoskeletons; and generating speech directly from thought. Getting there requires vaulting over one other hurdle that has nothing to do with science: These startups have to become real businesses, says Justin Sanchez, former head of brain-implant research at the Pentagon's R&D arm, the Defense Advanced Research Projects Agency. It's possible one could one day become a medical-device giant in its own right. But most of these companies are likely to run out of money or get acquired by big medical-technology companies, first. Whatever happens, brain-computer interfaces have advanced far enough that experts agree they can already give doctors new ways to improve patients' lives, and are likely to show up in many more of our heads in the future. Write to Christopher Mims at
Irish Times
01-05-2025
- Health
- Irish Times
‘Great progress' in the race to turn brainwaves into fluent speech
Neuroscientists are striving to give a voice to people unable to speak in a fast-advancing quest to harness brainwaves to restore or enhance physical abilities. Researchers at universities across California, and companies such as New York-based Precision Neuroscience, are among those making headway towards generating naturalistic speech through a combination of brain implants and artificial intelligence. Investment and attention have long been focused on implants that enable severely disabled people to operate computer keyboards, control robotic arms or regain some use of their own paralysed limbs. But some labs are making strides by concentrating on technology that converts thought patterns into speech. 'We are making great progress – and making brain-to-synthetic voice as fluent as chat between two speaking people is a major goal,' says Edward Chang, a neurosurgeon at the University of California, San Francisco. 'The AI algorithms we are using are getting faster, and we are learning with every new participant in our studies.' READ MORE Chang and colleagues, including from the University of California, Berkeley, last month published a paper in Nature Neuroscience detailing their work with a quadriplegic woman – paralysed limbs and torso – who had not been able to speak for 18 years after suffering a stroke. She trained a deep-learning neural network by silently attempting to say sentences composed using 1,024 different words. The audio of her voice was created by streaming her neural data to a joint speech synthesis and text-decoding model. The technique reduced the lag between the patient's brain signals and the resultant audio from the eight seconds the group had achieved previously to one second. This is much closer to the 100-200 millisecond time gap in normal speech. The system's median decoding speed was 47.5 words per minute, or about a third the rate of normal conversation. Even if you could, you wouldn't want people to hear your inner speech — Nick Ramsey of University Medical Centre Utrecht. Many thousands of people a year could benefit from so-called voice prosthesis. Their cognitive functions remain more or less intact but they have suffered speech loss due to stroke, the neurodegenerative disorder ALS and other brain conditions. If successful, researchers hope the technique can be extended to help people who have difficulty vocalising because of conditions such as cerebral palsy or autism. The potential of voice neuroprosthesis is beginning to trigger interest among businesses. Precision Neuroscience claims to be capturing higher-resolution brain signals than academic researchers, since the electrodes of its implants are more densely packed. The company has worked with 38 patients and plans soon to collect data from more, providing a potential pathway to commercialisation. Precision received regulatory clearance on April 17th to leave its sensors implanted for up to 30 days at a time. That would enable its scientists to train their system with what could within a year be the 'largest repository of high-resolution neural data that exists on planet Earth', says chief executive Michael Mager. The next step would be to 'miniaturise the components and put them in hermetically sealed packages that are biocompatible so they can be planted in the body forever', says Mager. [ Brain tech breakthrough restores ALS patient's ability to speak Opens in new window ] Elon Musk's Neuralink, the best-known brain-computer interface (BCI) company, has focused on enabling people with paralysis to control computers rather than giving them a synthetic voice. An important obstacle to the development of brain-to-voice technology is the time patients take to learn how to use the system. A key unanswered question is how much the response patterns in the motor cortex – the part of the brain that controls voluntary actions, including speech – vary between people. If they remained very similar, machine-learning models trained on previous individuals could be used for new patients, says Nick Ramsey, a BCI researcher at University Medical Centre Utrecht. That would accelerate a process that today takes 'tens or hundreds of hours, generating enough data by showing a participant text and asking them to try to speak it'. Ultimately a voice neuroprosthesis should provide the full expressive range of the human voice Ramsey says all brain-to-voice research focuses on the motor cortex where neurons activate the muscles involved in speaking, with no evidence that speech could be generated from other brain areas or by decoding inner thoughts. 'Even if you could, you wouldn't want people to hear your inner speech,' he adds. 'There are a lot of things I don't say out loud because they wouldn't be to my benefit or they might hurt people.' The development of a synthetic voice as good as healthy speech could still be 'quite a ways away', says Sergey Stavisky, co-director of the neuroprosthetics lab at University of California, Davis. His lab has demonstrated it can decode what someone is trying to say with about 98 per cent accuracy, he says. But the voice output isn't instantaneous and it doesn't capture important speech qualities such as tone. It is unclear if the recording hardware – electrodes – being used can enable the synthesis to match a healthy human voice, he adds. Scientists need to develop a deeper understanding of how the brain encodes speech production and better algorithms to translate neural activity into vocal outputs, says Stavisky. 'Ultimately a voice neuroprosthesis should provide the full expressive range of the human voice, so that for example they can precisely control their pitch and timing and do things like sing.' – Copyright The Financial Times Limited 2025
Yahoo
17-04-2025
- Business
- Yahoo
A rival to Elon Musk's Neuralink scored a big win
Elon Musk's Neuralink has been a trailblazer in brain chip implant technology. But today, rival company Precision Neuroscience announced that a core component of its brain implant system has been approved by the U.S. Food and Drug Administration. Precision Neuroscience said it has received 510(k) clearance from the FDA for the Layer 7 Cortical Interface, the company's high-resolution cortical electrode array — for use in the recording, monitoring, and stimulation of electrical activity on the surface of the brain. The Precision Neuroscience website describes a Layer 7 Cortical Interface as: A thin film microelectrode array that is engineered to conform to the brain's cortex without damaging tissue. The array is a core component of Precision's fully implantable, wireless, brain–computer interface system, which is currently in development. With this clearance, the Layer 7 Cortical Interface is now authorized for commercial use with implantation durations of up to 30 days. Musk's company describes its brain implant technology as a ' brain-computer interface that is fully implantable, cosmetically invisible, and designed to let you control a computer or mobile device anywhere you go.' Neuralink is currently looking for quadriplegics to participate in trials to see if its chips could give them more mobility. At brain implant technology's core, it's designed to stimulate the brain to communicate with external devices. This is a foundational moment for Precision,' said Benjamin Rapoport, the company's co-founder and chief science officer. 'By introducing the Layer 7 Cortical Interface into clinical settings, we'll be able to deliver immediate value for patients and neurosurgical teams, enabling real-time neural recording at a fidelity and scale not previously possible.' For the latest news, Facebook, Twitter and Instagram.
Forbes
17-04-2025
- Business
- Forbes
FDA Approves Neuralink Rival's Brain Implant
The Food and Drug Administration on Thursday approved a core component of a brain implant made by Precision Neuroscience, a company created by a cofounder of Elon Musk's Neuralink that claims its implant could be used to assist patients with severe paralysis—a clearance that comes as biotech companies reportedly face challenges for regulatory approval under the Trump administration. Precision Neuroscience said its brain implant system could help patients with severe paralysis. Precision said Thursday the FDA approved its Layer 7 Cortical Interface, a component of the company's brain-computer interface implant that helps record, monitor and stimulate electrical activity on the brain's surface. The FDA's clearance allows Precision to implant Layer 7 in patients for up to 30 days and market the technology for use in clinical applications, including during procedures to map brain signals, the company said. Precision announced it will expand its clinical research program for the implant, after the company had already tested the device in 37 patients, as the FDA's approval allows Precision to collect data over weeks instead of hours. A spokesperson for Precision told Bloomberg the company expects to start selling the device in 2026 (Precision did not immediately respond to a request for comment from Forbes). Get Forbes Breaking News Text Alerts: We're launching text message alerts so you'll always know the biggest stories shaping the day's headlines. Text 'Alerts' to (201) 335-0739 or sign up here. Precision's Layer 7 implant is a small, yellow device thinner than a piece of hair made up of 1,024 electrodes, or a conductor that carries electrical signals. The electrodes can detect electrical activity on the brain's surface, allowing researchers or medical practitioners to better observe which parts of the brain are in use, according to Precision. The company has marketed its implant as minimally invasive and claims the product could restore functions like speech and movement among patients with paralysis. Some clinical trials and drug tests by biotech companies have been delayed as mass layoffs impair functions at the FDA, people familiar with the matter told The Wall Street Journal. One company, Daré Bioscience, told the Journal a late-stage study of a treatment for a sexual-arousal disorder in women was delayed indefinitely, as the FDA has pushed back a date when it would provide guidance on how to measure the study's results. The FDA said in a statement to Forbes the agency is 'actively working to ensure continuity of operations during the reorganization period and remains committed to ensuring critical programs and testing continue.' Benjamin Rapoport cofounded Precision Neuroscience in 2021, four years after he helped cofound Musk's Neuralink. Precision is one competitor for Musk's brain implant company, including Blackrock Neurotech and Synchron, a company backed by Amazon founder Jeff Bezos and Bill Gates. Precision raised about $102 million in venture capital funding in December, bringing the company's total funding to $155 million. Neuralink implanted a brain chip in its first human subject last year, and the company has since implanted two other patients as of January, Musk said. Musk said the company expected to implant between 20 and 30 more patients in 2025, as Musk has claimed Neuralink's implant could bestow 'cybernetic powers' on people and allow people to control robots with their mind. He has also claimed the device could help treat epilepsy and fully cure paralysis, an issue Musk said is a 'tough problem, but ultimately solvable.' Some experts have criticized Neuralink for its lack of transparency, however, as some raised questions about patient safety and risks pushing back the neurotechnology industry. Elon Musk's Neuralink Prepares To Implant Second Human Patient (Forbes)
