Layer 7 Cortical Interface of Precision Neuroscience
Courtesy of precision neuroscience
Neurotech Startup Precision Neuroscience announced Thursday that the core components of its brain implant system have been approved by the US Food and Drug Administration, a major victory for businesses four years ago.
Accuracy is the construction of a brain computer interface or BCI. This is a system that deciphers neural signals and converts them into commands from external technology. The company’s BCI is initially used to help patients with severe paralysis recover functions such as speech and movement, according to its website.
Only a portion of Precision’s system was approved by the FDA on Thursday, but marks the first full regulatory clearance granted to the company that developed the wireless BCI, Precision said in the release. Other notable startups in the space include Elon Musk’s Neuralink and Synchron. Amazon With founder Jeff Bezos Microsoft co-founder Bill Gates.
“This is a fundamental moment of precision,” said Dr. Benjamin Rapoport, co-founder and chief science officer of Precision, in a statement. Rapoport also co-founded Mask Neuralink in 2017 before departing the following year.
Precision Neuroscience Stephanie Rider inspects the company’s microelectrode array.
Source: Precision Neuroscience
The FDA approved system of accuracy is called the Layer 7 cortical interface. The microelectrode array is thinner than human hair and resembles yellow scotch tape. Each array consists of 1,024 electrodes that can record, monitor and stimulate electrical activity on the surface of the brain.
When placed in the brain, it states that accuracy can fit onto the surface without damaging the tissue.
The FDA has approved Layer 7 implanted in patients for up to 30 days, and the accuracy can be sold to market technology used in clinical settings. This means that the surgeon can use the array during the procedure to map, for example, brain signals. This is not a precision goal for technology, but it helps the company to generate revenue in the short term.
Precision has temporarily implanted layer 7 in 37 patients so far, and CNBC observed one case at Mount Sinai Hospital in New York last April. Up to this point, patients who had already undergone brain surgery for medical reasons have often been performed for a short period of minutes or hours.
Now, FDA clearance allows companies to collect data for a much longer period of time.
“This regulatory clearance will help us to exponentially increase access to diverse, high-quality data and build a more effective BCI system,” Rapoport said.
