A device that transmits brain signals from patients wirelessly to a computer has received approval in the United States for the first time. This approval is expected to lead to advancements in real-time monitoring of brain conditions during surgery, as well as technologies for correcting brain signals to treat diseases and decode the thoughts of paralyzed patients.
Precision Neuroscience in the United States announced on the 17th (local time) that its brain-computer interface (BCI) device, which captures and monitors electrical signals from the brain's surface and provides electrical stimulation, has received 510(k) marketing authorization from the Food and Drug Administration (FDA).
Precision noted, "We are the first among corporations developing wireless BCI to receive regulatory approval," adding, "This will be a significant milestone in the commercialization of BCI technology."
BCI is a technology that connects the brain and computers to restore bodily functions or convey human intentions to external devices. Electrodes implanted in the brains of paralyzed patients capture thoughts to operate robots or computers, translating them into text or speech. Established in 2021, Precision Neuroscience aims to help patients with total paralysis speak or move again through this technology.
The device from Precision that received FDA approval is called the "Layer 7 Cortical Interface," which is a film-like device thinner than a hair. It contains 1,024 ultra-small electrodes. This device can be attached to the brain's surface to detect neural signals or provide electrical stimulation back to the nerve cells.
The Layer 7 device has been temporarily implanted in 37 patients and used during brain surgeries for periods ranging from minutes to hours. With this FDA approval, the device can now be implanted in a patient's brain for up to 30 days to collect data, enabling more precise and long-term research.
Precision plans to first utilize the Layer 7 device for precise measurement of brain signals during surgeries in hospitals to generate revenue. At the same time, the accumulated data is expected to significantly enhance the performance of artificial intelligence (AI) for decoding neural signals.
Benjamin Laporport, chief scientific officer (CSO) and co-founder of Precision, said, "This approval is an important moment for Precision," adding, "We can collect more diverse and high-quality neural data to develop precise and effective BCI systems."
BCI is well known for being established by Elon Musk's Neuralink. Neuralink received clinical trial approval from the FDA in 2023 and has so far implanted BCI devices in three brains. A paralyzed patient successfully played chess using the BCI device to control the cursor on a laptop.
Precision is in a competitive relationship with Neuralink. CSO Laporport was a founding member of Neuralink. He left Neuralink in 2018 to establish Precision to develop a safer BCI. While Neuralink’s method involves inserting ultra-fine electrodes into the brain, Precision aims to differentiate its technology by attaching film electrodes to the brain's surface to minimize brain damage.