6. Brain-computer interfacing

People who have lost the ability to move or their sense of touch got a boost in March when the FDA released draft guidance to help developers of brain/computer interface (BCI) devices to pass regulatory hurdles on their way to investigational device exemptions.

The FDA defines (BCI) devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. Examples of these devices are being developed worldwide.

Companies including NeuroSky and Emotiv have developed EEG headsets that not only work for gaming, but help people recovering from a stroke or who have neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) to regain their independence.

Researchers at Battelle and  The Ohio State University Wexner Medical Center worked together to develop a BCI called NeuroLife that helps paralyzed people to regain conscious control of their fingers, hand and wrist.

A Swedish woman with a hand amputation recently became the first recipient of an osseo-neuromuscular implant to control a dexterous hand prosthesis. In 2017, an international research team developed a BCI that can read brain chemistry to enable communication in patients who are paralyzed and unable to talk. The FDA has put a particular focus on helping paralyzed military veterans and those who have amputations to regain physical function.

Having clear direction early in the process may help device developers in this rapidly evolving field save money and reduce risk, then-FDA Commissioner Dr. Scott Gottlieb said in March.

“There are many ways we identify these areas,” Gottlieb added. “Once we do, we work to ensure that the tools are in place to advance the development of these new technologies, by providing clarity and direction to medical device developers to help reduce the barriers of bringing new treatments to patients.” – NC

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