FDA Clears Precision Neuroscience’s Minimally Invasive Brain Implant, Marking Milestone for Neuralink Rival

Precision Neuroscience, a prominent challenger in the brain-computer interface (BCI) sector, has secured U.S. Food and Drug Administration (FDA) clearance for its cutting-edge Layer 7 Cortical Interface—a key component of its wireless brain implant system. The green light marks a major milestone for the company, granting full regulatory approval to test the implant in humans for up to 30 days. It also signals progress in the race to develop neurotechnologies aimed at restoring functions such as movement and speech to patients with severe paralysis.

A Breakthrough in Minimally Invasive Brain Interfaces

The FDA clearance centers on the Layer 7 Cortical Interface, a wafer-thin, flexible electrode array designed to rest on the surface of the brain without penetrating tissue. At just one-fifth the thickness of a human hair, the array features 1,024 platinum electrodes supported by a polyimide substrate, allowing it to flex and conform to the brain’s contours. The design is crucial for minimizing tissue damage and offers a reversible, less risky alternative to more invasive BCI systems.

Precision Neuroscience’s implantation strategy is equally groundbreaking. Employing what it calls a “micro-slit” technique, the system can be inserted through a sub-millimeter incision in the skull—sidestepping the need for a craniotomy. Using real-time imaging and fiberoptic endoscopy, surgeons can place multiple arrays with millimeter-level accuracy, potentially covering large cortical areas with minimal trauma. In one recent operation at Mount Sinai, surgeons deployed four arrays totaling 4,096 electrodes—an industry record for density in human BCI trials.

Engineering for Safety, Scalability, and Signal Fidelity

At the core of Precision’s approach is a focus on high-resolution neural data collection with minimal invasiveness. Each electrode in the Layer 7 array measures between 50 and 380 microns in diameter—approximately the size of a single neuron—and is arranged at a density of 683 electrodes per square centimeter. This offers roughly 625 times the spatial resolution of conventional clinical electrode strips.

This level of granularity allows for micron-scale signal capture, crucial for developing more sophisticated neural decoding algorithms. The extended 30-day implantation window granted by the FDA will allow Precision to gather the long-duration datasets necessary to refine these algorithms—particularly those using machine learning to interpret complex and noisy neural signals.

Scalability is another key differentiator. Unlike some BCI platforms that involve deep penetration into brain tissue, the Layer 7 arrays can be placed on the surface and linked together to expand coverage without increasing the risk of damage. The recent Mount Sinai deployment covered eight square centimeters of cortical surface, significantly more than comparable systems like Neuralink, which typically use fewer electrodes inserted deeper into the brain.

Clinical and Institutional Support

Precision’s technology has already been tested in more than 35 patients, with trials conducted at major institutions including Mount Sinai Health System, the University of Pennsylvania, and the WVU Rockefeller Neuroscience Institute. These studies have focused on validating the system’s safety, effectiveness, and precision in capturing neural activity in real-world clinical environments.

By offering a device that is both reversible and significantly less invasive, Precision Neuroscience is positioning itself as a safer and more scalable alternative in the burgeoning BCI landscape. This strategy directly contrasts with Neuralink’s approach, which involves surgically embedding threads into brain tissue and faces higher barriers in terms of safety, reversibility, and regulatory approval.

Implications for the BCI Industry

The FDA’s clearance represents the first full regulatory authorization for a wireless BCI aimed at short-term clinical applications. It provides a regulatory blueprint for future innovations in neural interfaces, especially those prioritizing minimally invasive methods. As BCI technologies edge closer to real-world therapeutic applications, Precision’s achievement could catalyze further investment and accelerate the pace of clinical adoption.

With demand growing for technologies that can help restore lost neurological functions and the BCI market heating up with well-funded players, Precision Neuroscience has carved out a distinctive path. Its focus on patient safety, ease of implantation, and high-resolution data collection sets a new benchmark for the field—and adds serious competition to Elon Musk’s Neuralink in the race to bring BCIs from the lab to the clinic.