🧠 FDA Clears Precision Neuroscience’s High-Resolution Cortical Interface

Precision Neuroscience has received FDA 510(k) clearance for its Layer 7 Cortical Interface, a high-resolution electrode array designed to record, monitor, and stimulate electrical activity on the brain's surface. This device, a core component of the company's developing wireless brain–computer interface (BCI) system, is now authorized for commercial use with implantation durations of up to 30 days.

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Extended Implantation: The clearance allows the device to remain implanted for up to 30 days, enabling longer-term neural data collection compared to previous short-duration uses during neurosurgical procedures.
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​Clinical Applications: The Layer 7 Cortical Interface is intended for intraoperative brain mapping and other clinical applications, providing real-time neural recording at unprecedented fidelity and scale.
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Clinical Trials: To date, the device has been tested in 37 patients through partnerships with institutions such as 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.
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​Data for AI Development: Extended implantation durations will enhance the company's ability to gather high-quality neural data, which is essential for improving the performance of its AI-driven BCI systems.

1. 🧠 Electrocorticography (ECoG): Strengths and Emerging Roles

ECoG offers superior spatial and temporal resolution over scalp EEG, without the invasiveness of penetrating microelectrodes. Neurologists increasingly use it not only for intraoperative mapping and seizure localization, but now also in brain–computer interface (BCI) trials. The Layer 7 array pushes this modality forward with longer implantation duration and greater coverage.

2. 🔌 Brain–Computer Interfaces in Clinical Neurology: From Assistive to Restorative

BCIs are rapidly transitioning from lab demos to clinical tools for restoring communication, mobility, or sensorimotor feedback in patients with paralysis, ALS, or brainstem stroke. Layer 7 is positioned as a bridge between acute neurophysiology and implantable BCI platforms, which neurologists may soon need to evaluate for select patients.

3. 🧪 The Role of Subacute Monitoring Devices in Epilepsy and Tumor Surgery

For neurologists managing refractory epilepsy or glioma, tools like Layer 7 enable longer-duration monitoring with high spatial fidelity, capturing seizure onset zones or eloquent cortex activity beyond what intraoperative mapping alone allows. This fills a gap between scalp EEG and chronic stereo-EEG/depth electrodes.

4. 🆚 Comparison of Emerging Cortical BCI Platforms: Precision vs. Synchron vs. Neuralink

Precision Neuroscience uses a surface-level ECoG array with scalable coverage. In contrast:

• Synchron implants a stent-like array in brain vasculature (minimally invasive but lower resolution)
• Neuralink/Blackrock implant penetrating microelectrodes (high resolution but higher risk)
  Neurologists should understand the trade-offs in signal quality, invasiveness, and long-term usability as clinical options diversify.

5. 📊 AI-Driven Signal Decoding and the Need for Rich Neural Datasets

BCI accuracy depends on high-quality, stable neural recordings — the kind Layer 7 enables. For neurologists collaborating on BCI trials, understanding how these data support real-time decoding of speech, movement, or cognition is essential to advancing both patient care and clinical research in neurotechnology.

📚 References

1. Precision Neuroscience. (2025). FDA Clearance for High-Resolution Cortical Electrode Array. https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html​
2. Chaudhary, U., et al. (2022). Brain–computer interface-based communication in the completely locked-in state. Nature Communications, 13, 1236.
3. Miller, K. J., et al. (2007). Spectral changes in cortical surface potentials during motor movement. Journal of Neuroscience, 27(9), 2424–2432.
   – Foundational study on ECoG use in motor decoding.
4. Musk, E., & Neuralink. (2021). An integrated brain-machine interface platform with thousands of channels. Journal of Medical Internet Research, 23(11):e16864.
   – Overview of Neuralink’s approach to cortical interfacing.
5. Oxley, T. J., et al. (2021). Motor neuroprosthesis implanted using minimally invasive neurointervention. Nature Biomedical Engineering, 5, 1038–1045.
   – Key study on Synchron’s endovascular BCI platform.
6. Vansteensel, M. J., et al. (2016). Fully implanted brain–computer interface in a locked-in patient with ALS. New England Journal of Medicine, 375, 2060–2066.
7. Chang, E. F., & Lim, D. A. (2016). Neurophysiological monitoring and cortical mapping for brain tumor surgery: essential tools for preserving function. Nature Reviews Neurology, 12(8), 429–442.
8. Gilron, R., et al. (2021). Long-term neural recording using a flexible ECoG array. Science Translational Medicine, 13(614), eabb0187.
9. FDA. (2024). 510(k) Summary for Electrocorticography (ECoG) Recording Devices. https://www.fda.gov (search: "ECoG 510k")