Precision Neuroscience’s Layer 7 Cortical Interface: FDA Approval and the Future of Minimally Invasive Brain Implants

Key Takeaways

• Precision Neuroscience’s Layer 7 Cortical Interface is the first wireless BCI component to receive full FDA clearance for temporary implantation.
• The device uses a minimally invasive “micro-slit” technique, requiring only a sub-millimeter incision in the skull for placement.
• Each flexible array contains 1,024 electrodes—one-fifth the thickness of a human hair—enabling unprecedented resolution in neural recording and stimulation.
• The system is designed for safe, reversible implantation and removal, minimizing risk of brain tissue damage.
• Clinical studies have demonstrated successful deployment of up to four arrays in a single patient, totaling 4,096 electrodes across 8 square centimeters.
• FDA approval allows the device to remain implanted for up to 30 days, enabling long-term neural data collection for improved AI decoding.
• The Layer 7 interface is already in use at leading institutions, including Mount Sinai and Penn Medicine, for brain mapping during surgery.
• Precision’s approach stands apart from competitors like Neuralink by avoiding tissue penetration and prioritizing patient safety.
• The data gathered is expected to accelerate development of AI-driven neural decoding, with commercial launch targeted for 2026.

A New Era for Brain-Computer Interfaces: The FDA’s Landmark Approval

• Precision Neuroscience’s FDA clearance marks the first comprehensive regulatory endorsement for a wireless brain-computer interface component, signaling a major leap forward for the field.
• The Layer 7 Cortical Interface is designed to interpret neural signals and convert them into actionable commands, with initial applications focused on restoring speech and movement for patients with severe paralysis.
• This approval allows the device to be implanted for up to 30 days, expanding research capabilities from brief surgical windows to long-term neural data collection.
• The regulatory milestone positions Precision as a frontrunner among BCI innovators, alongside competitors like Neuralink and Synchron.
• Precision’s leadership team includes Dr. Benjamin Rapoport, a former Neuralink co-founder, who emphasizes the company’s commitment to safety and clinical utility.
• The company has raised over $100 million in venture capital, reflecting strong investor confidence in its vision and technology.

The FDA’s decision enables Precision to offer its device for clinical use in brain mapping during open surgery, while also advancing its broader goal of developing a computer-controlling platform for neurological patients.

Layer 7 Cortical Interface: Ultra-Thin, High-Density Electrode Array

• The Layer 7 device is a thin-film microelectrode array, just one-fifth the thickness of a human hair, designed to conform precisely to the brain’s surface.
• Each array contains 1,024 platinum microelectrodes, spanning an area of approximately 1.5–1.6 square centimeters, with electrode diameters as small as a single neuron.
• The flexible polyimide backing allows the array to sit in the subdural space without penetrating brain tissue, reducing the risk of inflammation or damage.
• Modular design permits multiple arrays to be placed side by side, enabling mapping of larger cortical regions with exceptional detail.
• In a record-setting procedure at Mount Sinai, four arrays (totaling 4,096 electrodes) were deployed simultaneously, covering 8 square centimeters of cortex.
• This density delivers approximately 625 times the spatial resolution of standard clinical electrode strips, capturing neural signals at the micron scale.
• The device is engineered for both recording and stimulation, supporting a wide range of clinical and research applications.
• Its reversibility means it can be safely removed without causing harm, a key differentiator from more invasive BCI systems.

The Layer 7’s high-resolution mapping capability opens new avenues for understanding and treating complex neurological conditions.

Minimally Invasive “Micro-Slit” Implantation: Safety and Scalability

• Precision’s implantation technique uses a “cranial micro-slit”—a sub-millimeter incision made tangentially to the cortical surface—to insert the flexible array.
• The procedure eliminates the need for traditional craniotomies, reducing surgical risk, recovery time, and patient discomfort.
• Real-time imaging and fiberoptic endoscopy guide the placement, ensuring precise positioning of the array on the cortical surface.
• The approach is reversible and atraumatic, designed to avoid damage to both the brain and the surrounding tissue.
• Multiple arrays can be inserted rapidly—over 1,000 electrodes per minute—enabling coverage of large brain regions in a single procedure.
• Clinical studies have demonstrated successful, safe deployment and removal of the device in over 35 patients at top medical centers.
• The minimally invasive method is a major step toward making BCIs more accessible and acceptable for a wider range of patients.
• By avoiding tissue penetration, Precision’s method stands apart from competitors, offering a safer alternative for both research and therapeutic use.

This technique not only enhances patient safety but also paves the way for broader adoption of BCI technology in clinical settings.

Clinical Impact and Research Applications

• The Layer 7 Cortical Interface has been tested in feasibility studies at Mount Sinai, Penn Medicine, and the Rockefeller Neuroscience Institute.
• In these studies, the device has been temporarily placed during neurosurgical procedures to record high-resolution brain activity and map functional regions.
• The FDA’s approval for up to 30 days of implantation allows for extended data collection, critical for developing robust neural decoding algorithms.
• Data gathered from the device is compared to standard-of-care cortical surface arrays, demonstrating superior spatial resolution and signal fidelity.
• The technology is being explored for use in diagnostic electrophysiology mapping, brain-controlled movement, and restoration of speech in paralyzed patients.
• Early clinical results have been described as “remarkable,” with surgeons able to observe brain activity in real time at an unprecedented level of detail.
• The device’s modular, reversible design enables researchers to study larger brain areas and more complex neural networks.
• Precision aims to expand its clinical research program, with additional studies planned at major medical centers across the U.S.

These advances are expected to accelerate the development of AI-powered BCIs capable of restoring lost functions and improving quality of life for patients with neurological disorders.

Precision Neuroscience vs. Neuralink: Divergent Paths to the Future of BCI

• Precision Neuroscience was founded by Dr. Benjamin Rapoport, a former Neuralink co-founder, with the goal of developing a safer, more reversible BCI.
• While Neuralink’s approach involves inserting ultra-fine electrodes deep into brain tissue, Precision’s Layer 7 device attaches film electrodes to the brain’s surface, minimizing potential for damage.
• Both companies target similar applications—restoring movement, speech, and independence for paralyzed patients—but differ fundamentally in their surgical and technological strategies.
• Precision’s minimally invasive, surface-based method is designed for reversibility and broader clinical acceptance.
• Neuralink has faced regulatory hurdles and public scrutiny over animal welfare, while Precision’s FDA clearance positions it as a leader in responsible BCI development.
• The Layer 7’s modularity and high electrode density set new records in human BCI research, outpacing competitors in data collection capability.
• Precision anticipates commercial launch of its implant in 2026, with a focus on both clinical and research markets.
• The company’s emphasis on safety, scalability, and data-driven innovation could shape the future landscape of neurotechnology.

As the race for advanced BCIs heats up, Precision’s FDA-approved platform stands out for its patient-centric design and clinical readiness.

Precision Neuroscience’s FDA-approved Layer 7 Cortical Interface ushers in a new era of minimally invasive, high-resolution brain-computer interfaces with the potential to transform care for patients with neurological disorders. With its reversible design, scalable electrode density, and commitment to safety, Precision is poised to lead the next wave of innovation in neurotechnology.