Precision Neuroscience

During removal of a right parafalcine meningioma, surgeons placed four Layer 7 μECoG arrays, 4,096 electrodes in total, on either side of the central sulcus and recorded somatosensory evoked potentials under 5 contralateral stimulation conditions. Using a 2 MΩ impedance cutoff, 3,739 channels were usable, a 91.3% yield; phase-reversal latencies were 19, 21, 25, 26 and 25 ms, consistent with the standard intraoperative mapping performed in the same operation. The researchers caution that the setup provides dense spatial sampling rather than submillimeter physiological resolution: measured responses were correlated across roughly 3–4 mm of cortex.

A workshop at the BCI Society Meeting 2025, run with the Implantable BCI Collaborative Community (iBCI-CC), took up how clinical outcome assessments (COAs) for pivotal BCI trials should be selected, developed and validated. Participants pointed to patient heterogeneity, the absence of widely validated COAs, and the difficulty of capturing outcomes that matter in home and daily-life settings. The discussion lays groundwork for the iBCI-CC Clinical Study Endpoints Workgroup to build a transparent process for identifying meaningful aspects of health and concepts of interest, in support of regulatory approval and reimbursement.

The FDA has cleared Precision Neuroscience's Layer 7 Cortical Interface to stay implanted for up to 30 days, up from a previous 510(k) limit of 30 minutes of intraoperative use. The longer window opens the door to extended clinical studies and marks an intermediate step toward a permanent implant.

Placing electrodes on the brain's surface rather than inserting them into tissue is the key difference between Precision Neuroscience's approach and the BrainGate approach Donoghue pioneered. The New York-based company develops minimally invasive, safely removable, high-bandwidth BCIs; its first system, Layer 7, is aimed at people with ALS, spinal cord injury and brainstem stroke, a population the company estimates at 315,000 in the US. The company says its Layer 7 cortical surface array has been implanted in nearly 100 patients at several leading academic medical centers, that it has raised $180 million from investors, and that it has received FDA 510(k) clearance. Donoghue, a professor emeritus at Brown University, will advise on device design, signal decoding and clinical strategy as the company pushes ahead with a long-term implant study and commercial launch.

A Neurosurgical Focus paper tested Precision Neuroscience's 1,024-channel Layer 7 micro-ECoG array in four awake-craniotomy patients. Four-word speech classification reached 77.5% accuracy and four-direction cursor classification reached 78% to 84%, with no device-related adverse events reported during the procedures. The small, short intraoperative study was a feasibility test rather than a pivotal motor-restoration trial.