March 1, 2019

FDA Establishes Guidance for Brain-Computer Interface Technologies

The FDA has announced steps to promote the development of brain-computer interface technologies (BCI), going so far as to issue draft guidance that provide thoughts on clinical and non-clinical testing for software, biocompatibility, electrical safety, and more.

But what is brain computer interface? BCI is the process of capturing electric activity in the brain, either through a surgically implanted electrode or special electrode cap, and sending that information to a computer system which translates that activity to a command for an external device.

BCI has the potential to help patients regain lost mobility, interact more functionally with prosthetics, restore communication, and much more. Healthesystems previously reported on BCI, noting various BCI breakthroughs, including:

But BCI technology still has a way to go before we see products flooding the market. Currently the only FDA-approved BCI technology is the NeuroPace chip from 2013, which scans the brain for electric activity related to seizures, short circuiting said activity. Furthermore, BCI devices must gain some semblance of portability and consumer-friendly maintenance functionality, which may be difficult as several BCI devices must be surgically implanted.

However, the FDA’s interest in BCI indicates that health professionals should begin taking this technology more seriously. Not only did the FDA provide initial thoughts on regulatory considerations for BCI technologies, but they also established a 15-person team of experts to study the BCI landscape and prepare future recommendations. Furthermore, the FDA may soon conduct public workshops to foster discussion of scientific and clinical considerations associated with the development of BCI devices.

And it isn’t just the FDA taking notice. The Journal of the American Medical Association just re-featured information from a November PLOS One paper that described how BCI was used to help quadriplegics with implanted electrodes control personal tablets and perform common tasks such as web browsing, sending emails, instant messaging, and texting.

As the field of BCI continues to make breakthroughs, it will only be a matter of time before such technologies make their way into workers’ comp.

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