FDA Grants Breakthrough Device Status to Brain-Computer Interface

Brain–computer interface (BCI) company Precision Neuroscience Corporation (Precision) has acquired a microelectromechanical systems (MEMS) foundry outside Dallas. Completed through a wholly owned subsidiary, Precision BioMEMS Corporation, the acquisition brings the company’s supply chain in-house and establishes Precision as a leading-edge U.S. biomedical MEMS manufacturer.

The facility comprises a 22,000-square-foot building, including a 5,500-square-foot ISO class 5 clean room (a low-particle zone for manufacturing), more than 500 square feet of ISO class 6 post-processing and assembly space, and more than 50 specialized tools. Precision BioMEMS retained the facility’s team, which has deep expertise in both biomedical and general-purpose MEMS manufacturing. In addition to its work for Precision, Precision BioMEMS will continue to operate as a foundry serving other U.S. companies.

In addition, the company disclosed that its brain-computer interface system has been awarded U.S. Food and Drug Administration Breakthrough Device designation. Such designation expedites the review of new technologies designed to treat debilitating or life-threatening conditions.
 
Founded in 2021 by a team including neurosurgeon Benjamin Rapoport and business leader Michael Mager, Precision has created a direct communication pathway between the human brain and computers. The company completed first-in-human clinical studies of its device in April, mapping the human brain’s activity at an unprecedented level of detail. In coming years, Precision expects its minimally invasive brain implant to enable people with severe neurological conditions such as speech deficits and paralysis to regain independence, communicate with loved ones, and rejoin the workforce. The foundry acquisition gives Precision full production control of its core technology—a thin-film microelectrode array, called the Layer 7 Cortical Interface, which packs 1,024 electrodes into an area spanning 1.5 square centimeters—enabling a greater degree of quality management and the ability to iterate rapidly on future versions.
 
“To deliver brain–computer interface technology to the millions of people who stand to benefit, we need to rethink the medical device supply chain,” said Mager, Precision’s CEO. “High precision microfabrication is critical to building powerful brain–computer interfaces, and it will play an increasingly important role in medical device manufacturing going forward. Precision BioMEMS will help us build the neural technology of tomorrow while also advancing the broader U.S. medical device industry.”
 
Precision’s brain–computer interface is an investigational device and is not available for sale in the United States. 
 
Precision Neuroscience is working to provide breakthrough treatments for neurological illnesses. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large amounts of data.