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Precision Neuroscience Achieves FDA Approval for Innovative BCI Technology

Precision Neuroscience Achieves FDA Approval for Innovative BCI Technology

ABONE OL
Nisan 20, 2025 10:56
Precision Neuroscience Achieves FDA Approval for Innovative BCI Technology
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Precision Neuroscience’s Breakthrough in Brain-Computer Interfaces

US-based neurotechnology company Precision Neuroscience has reached a pivotal moment in the brain-computer interface (BCI) sector. The startup recently announced that it has secured approval from the US Food and Drug Administration (FDA) for a crucial element of its cutting-edge brain implant system, known as the “Layer 7 Cortical Interface”. This achievement marks a significant milestone for the company, which was founded only four years ago.

Precision Neuroscience's Breakthrough in Brain-Computer Interfaces

FDA Approval: A Critical Step for BCI Technology

Precision Neuroscience is pioneering a BCI system designed to assist individuals with severe paralysis in regaining essential functions like speech and movement. BCIs are systems that interpret brain signals to control external devices. The long-term ambition of the company is to enhance the quality of life for individuals living with disabilities through this technology.

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FDA Approval: A Critical Step for BCI Technology

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The FDA-approved component, known as the “Layer 7 Cortical Interface”, is an ultra-thin microelectrode array, finer than a human hair, which can be placed on the brain’s surface without causing damage. This yellow tape-like structure, composed of 1,024 electrodes, is capable of monitoring, recording, and stimulating brain activity.

Precision Neuroscience has previously conducted short-term tests on 37 patients using this system. With the new approval, the implant can now be installed in patients’ brains for up to 30 days and be regularly utilized in clinical environments.

Competition in the BCI Field

Dr. Benjamin Rapoport, the co-founder and chief scientific officer of Precision Neuroscience, was a founding member of Elon Musk’s Neuralink before departing after a year. Today, Rapoport has emerged as a formidable competitor in the BCI domain with his own innovative system. However, Precision Neuroscience and Neuralink are not alone in the BCI landscape. Other companies, such as Synchron, supported by prominent figures like Amazon’s Jeff Bezos and Microsoft’s Bill Gates, are also making strides in this field. Still, Precision is the first to receive full regulatory approval from the FDA for wireless BCI technology.

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