Precision Neuroscience, a prominent rival of Elon Musk-owned Neuralink, has announced that its brain-computer interface (BCI) system has received ‘Breakthrough Device’ designation from the US Food and Drug Administration (FDA). This technology is designed to read brain signals (the tiny electrical impulses the human brain uses to send information) and then translate those signals into commands that can control things like a computer, tablet, or even robotic limbs.
The FDA-approved flagship product – named ‘Layer 7 Cortical Interface’ – is a very thin, flexible device that is designed to sit directly on the surface of the brain, not deep inside it. It contains 1,024 electrodes within a one-square-centimetre area, embedded in a film thinner than a human hair. This design allows for high-resolution mapping of brain activity while minimizing invasiveness.
In fact, with the FDA’s approval, the company is now allowed to legally provide its brain implant (Layer 7 Cortical Interface) for use in real medical procedures – specifically, brain surgeries.
Founded in 2021, the neurotechnology startup conducted its first-in-human clinical trial in collaboration with the Rockefeller Neuroscience Institute at West Virginia University in 2023. During this study, the Layer 7 Cortical Interface was temporarily placed on the brains of three patients undergoing tumour resection surgeries. The device successfully recorded and mapped electrical activity from the brain’s surface, providing exceptional detail, particularly in regions responsible for language.
To date, the company has already tested this device (Layer 7) in 37 patients during surgeries, but the device was not left in permanently. It was used temporarily during those procedures to gather brain data. However, now that it is approved for use, Precision can start studying how the device performs over time, possibly in patients who have it implanted longer term (periods of up to 30 days as per approval).
In terms of finance, the company has raised a total of $183 million in funding over 5 rounds. In December 2024, Precision Neuroscience closed a $102 million Series C funding round.
However, despite belonging to a futuristic and still emerging field, Precision Neuroscience is facing tough competition from well-funded rivals like Elon Musk’s Neuralink, which has raised over $600 million to date. Even earlier this year, Musk announced that his neural interface technology company had completed its third human brain-chip implant. Neuralink (which performed its first human brain chip implant back in January 2024) plans to carry out about 20 to 30 more implants in 2025.
Additionally, beyond competition, Precision also faces challenges like a lack of skilled neurosurgeons, patients’ doubts about brain implants, and uncertainties around insurance reimbursement for such advanced tech. Also, ethical concerns about neuroprivacy and the potential misuse of neural data add further complexity.
