Dive Brief:
- Mass General Brigham has created a collaborative community to accelerate the development of implantable brain-computer interface (BCI) devices.
- The group, which Mass General Brigham disclosed Monday, brings BCI experts together with the Food and Drug Administration and other organizations to develop harmonized approaches to the technology.
- The collaborators aim to resolve the clinical, regulatory, coverage and payment questions facing developers of BCIs and thereby try to improve patient access to the technology.
Dive Insight:
BCI is a technology that receives and interprets brain signals and then translates them into commands to carry out a specific action. The technology is typically designed for people with physical disabilities, either genetic or from injury.
Researchers have spent decades advancing the science of BCIs, but the public profile of the technology has risen in recent years as companies such as Synchron and Elon Musk’s Neuralink have raised money to fund development of devices. Synchron in September said six patients received its implant in the company’s U.S.-based feasibility study, while Neuralink has also reportedly begun testing its technology in humans.
Against that backdrop, people from organizations including Massachusetts General Hospital have worked over the past year to organize a group to foster collaboration on BCIs. The work resulted in the creation of the Implantable Brain-Computer Interface Collaborative Community (IBCI-CC), one of 16 such groups that the FDA’s Center for Devices and Radiological Health (CDRH) participates in.
David McMullen, CDRH’s director of the office of neurological and physical medicine devices, said in a statement the community will “serve as an open venue to identify, discuss and develop approaches” to overcome the various hurdles that currently impede access to BCI devices. IBCI-CC will hold regular meetings with its members and the public to discuss challenges and how to overcome them.
The community will feature working groups on topics including user priorities, clinical trial endpoints and ethics. Through the groups, IBCI-CC aims to use regulatory science tools to support evidence generation and advance approaches that “drive continuous innovation and equitable access” to devices. IBCI-CC will initially focus on “regulatory and translation issues” in the U.S.
No companies are mentioned in the statement, but moves to commercialize the technology are referenced. Leigh Hochberg, a Mass General physician who helped establish IBCI-CC, said the “launch of multiple [implantable] BCI and related neurotech companies means that the time is right to identify common goals and metrics.”
Along with the FDA, participating organizations include Synchron, Neuralink, Precision, the BCI Society and Blackrock Neurotech.