Latest news with #Layer7CorticalInterface
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)
Associated Press
17-04-2025
- Business
- Associated Press
Precision Neuroscience Receives FDA Clearance for High-Resolution Cortical Electrode Array
NEW YORK, April 17, 2025 (GLOBE NEWSWIRE) -- Precision Neuroscience Corporation (Precision), a leader in brain–computer interface (BCI) technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Layer 7 Cortical Interface, its high-resolution cortical electrode array, for use in the recording, monitoring, and stimulation of electrical activity on the surface of the brain. 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. The clearance represents a major milestone for the brain–computer interface field, as it marks the first full regulatory clearance granted to a company developing a next-generation wireless BCI. It also paves the way for Precision to begin marketing its technology for clinical applications, such as intraoperative brain mapping. 'This is a foundational moment for Precision,' said Benjamin Rapoport, MD, PhD, Chief Science Officer and Co-Founder. '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.' Precision will follow the clearance with an expansion of its clinical research program. The company has tested its device in 37 patients to date through clinical study partnerships with leading research institutions, including Mount Sinai Health System, the Perelman School of Medicine at the University of Pennsylvania, West Virginia University's Rockefeller Neuroscience Institute, and Beth Israel Deaconess Medical Center. Additional collaborations will be announced later this year. These implants have, until now, been limited to short durations during neurosurgical procedures. This clearance allows Precision's technology to be deployed for longer durations, up to 30 days—for weeks at a time, instead of hours––opening up new possibilities for scientific discovery. Rapoport emphasized that extended implant durations will enhance Precision's ability to gather high-quality neural data, which is essential for improving the performance of its brain–computer interface systems. 'Neural decoding algorithms, like all AI-driven products, rely on vast amounts of data,' he said. 'This regulatory clearance will exponentially increase our access to diverse, high-quality data, which will help us to build BCI systems that work more effectively.' Michael Mager, Precision's CEO and Co-Founder, reflected on Precision's evolution from a startup to a clinical-grade medical technology company: 'In just four years since our founding, we've gone from an idea to achieving FDA clearance for our cutting-edge cortical array, which we manufacture in a facility that we own and operate. This is a testament to the extraordinary team we have attracted, and their ability to execute across multiple domains. Our mission is to deliver life-changing brain–computer interface technology to the millions of people who stand to benefit from it. This clearance represents a big step forward toward that goal.' About Precision Neuroscience Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illness. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large volumes of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit Media Contact: [email protected]
