About
Precision Neuroscience is a neurotechnology company pioneering high-bandwidth, minimally invasive brain-computer interface (BCI) technology. Their flagship product, the Layer 7 cortical interface, is a thin-film electrode array that creates a digital connection with the brain without causing harm—making it a significant step forward compared to traditional invasive neural implants. The primary application of the Layer 7 system is enabling individuals living with paralysis—caused by conditions such as ALS, spinal cord injury, cerebral palsy, or transverse myelitis—to operate computers, robotic devices, and other digital technology using only their neural signals. The device is designed to be both removable and upgradable, addressing longstanding concerns around the permanence of neural implants. Precision has achieved 510(k) FDA clearance for the Layer 7 cortical interface and is actively conducting clinical studies across 15+ hospital partners, including Mount Sinai, Johns Hopkins, Penn Medicine, Mass General Brigham, and Emory Healthcare, with 80+ patients implanted to date. The company's long-term vision includes expanding coverage to additional brain regions to unlock new possibilities for neurological treatment and discovery. Precision Neuroscience is a critical player in the growing BCI space, positioned to deliver meaningful improvements in quality of life for millions of people affected by paralysis and neurological disorders. It currently operates as an investigational device and is not yet commercially available for sale in the United States.
Key Features
- Layer 7 Cortical Interface: A thin-film, high-density electrode array that creates a high-bandwidth digital connection with the brain with minimal invasiveness and no tissue damage.
- Thought-Controlled Device Operation: Enables individuals with paralysis to control computers, robotic devices, and other digital tools using only their neural signals and thoughts.
- 510(k) FDA Clearance: The Layer 7 cortical interface has received FDA 510(k) clearance, validating its safety profile and marking a key regulatory milestone for the technology.
- Removable & Upgradable Design: Unlike many neural implants, the Layer 7 system is specifically engineered to be removable and upgradable without damaging brain tissue, reducing long-term risk.
- Scalable Brain Coverage: The platform is designed to expand to more brain regions over time, enabling future applications in neurological treatment, research, and discovery.
Use Cases
- Enabling individuals with ALS or spinal cord injury to control computers, tablets, and smart devices entirely through neural signals and thought.
- Restoring communication and creative expression for people with paralysis, such as drafting messages, browsing the internet, or engaging on social platforms.
- Supporting clinical neuroscience research at academic medical centers studying brain-computer interface technology and neural signal decoding.
- Providing a platform for robotic device control, potentially enabling paralyzed patients to operate assistive robotics through direct neural commands.
- Advancing the frontier of neural data collection and cortical mapping to inform future treatments for neurological conditions beyond paralysis.
Pros
- FDA Cleared: The Layer 7 interface holds 510(k) FDA clearance, providing a critical regulatory stamp of safety and efficacy that distinguishes it in the BCI landscape.
- Minimally Invasive & Reversible: The device is designed to be implanted without damaging the brain and can be removed or upgraded, addressing major patient and clinician concerns around permanence.
- Broad Clinical Network: Active partnerships with 15+ leading hospital systems—including Johns Hopkins, Penn Medicine, and Mass General Brigham—accelerate clinical research and adoption.
- Real-World Patient Impact: With 80+ patients implanted in clinical studies, the technology has demonstrated tangible results restoring independence for people with ALS, spinal cord injuries, and cerebral palsy.
Cons
- Not Commercially Available: The Layer 7 interface is currently an investigational device and is not approved for general commercial sale in the United States, limiting patient access.
- Requires Surgical Implantation: Despite being minimally invasive relative to other BCIs, the device still requires a surgical procedure, carrying inherent medical risks and access barriers.
- Early-Stage Clinical Availability: Participation is limited to clinical study sites and approved hospital partners, meaning most patients cannot yet access the technology outside of research settings.
Frequently Asked Questions
What is the Layer 7 cortical interface?
The Layer 7 cortical interface is Precision Neuroscience's flagship brain-computer interface device—a thin-film, high-density electrode array implanted on the brain's surface that records neural signals and translates them into digital commands, enabling thought-based control of computers and robotic devices.
Is Precision Neuroscience's device FDA approved?
Yes. The Layer 7 cortical interface has received 510(k) clearance from the FDA. However, it remains an investigational device and is not currently approved for commercial sale in the United States.
Who is this technology designed for?
The primary beneficiaries are individuals living with paralysis due to conditions such as ALS, spinal cord injury, cerebral palsy, or transverse myelitis, who can use the interface to regain the ability to control digital devices independently.
How is Precision Neuroscience different from Neuralink?
While both develop BCIs, Precision Neuroscience emphasizes a minimally invasive approach with the Layer 7 interface, which is designed to be removable and upgradable without damaging brain tissue—a distinction often highlighted in the company's clinical and safety-focused positioning.
How can hospitals or clinicians partner with Precision Neuroscience?
Clinicians and hospital systems can reach out through the Precision Neuroscience website via the 'Partner With Us' contact pathway to explore becoming a clinical study site or research partner.
