Dive Brief:
- Precision Neuroscience received 510(k) clearance for an electrode array that can be implanted for up to 30 days to map brain activity, the company announced Thursday.
- The clearance is a milestone for the New York-based startup, which plans to use the electrode array as part of a brain-computer interface that is currently in development.
- Precision Neuroscience said the decision was the first time a company developing a next-generation wireless BCI has received FDA clearance, as it competes with rivals including Elon Musk’s Neuralink and Synchron, whose backers include Jeff Bezos and Bill Gates.
Dive Insight:
Precision Neuroscience’s Layer 7 Cortical Interface is a thin microelectrode array that rests on the cerebral cortex, the brain’s outermost layer. It can be inserted by making a small incision in the skull.
The company began in-human clinical trials in June 2023 and has tested the implant in 37 patients. During those studies, the device was placed temporarily, such as to help surgeons remove brain tumors.
With the FDA clearance, the implant can now be placed for up to 30 days, allowing Precision Neuroscience to begin selling the technology for intraoperative brain mapping and to build a repository of high-resolution neural data. The company said it could use this data to train algorithms used in a BCI for functions like moving a robotic limb.
“In just four years since our founding, we've gone from an idea to achieving FDA clearance for our cutting-edge cortical array, which we manufacture in a facility that we own and operate,” CEO Michael Mager said in a news release.
Precision Neuroscience started in 2021, with its founders including Benjamin Rapoport, a neurosurgeon and founding member of Neuralink.
As of January, Musk has said that three patients received Neuralink implants.
Synchron has started a clinical trial, sharing one-year results of its implant in six patients in a September readout.
