Spurring Innovation of Brain-Computer Interface Devices FDA is continuing to encourage innovation in novel areas — the latest being novel brain implants, often referred to as brain-computer interface devices — that can help patients with paralysis or amputation gain mobility. In support of that goal, the agency released a draft guidance, “Implanted Brain-Computer Interface (BCI) De­vices for Patients with Paralysis or Amputation – Non-clinical Testing and Clinical Considerations.”

These implantable devices hold great promise for those with limited or no ability to speak. They can also enable patients to use their thought to control a limb prosthesis. These devices directly impact a person’s quality of life, whether offering them greater mobility or greater independence.

“Our voices help connect us to our friends, family and the world around us, which is why losing the power of one’s voice due to injury or disease is so devastating,” says Nima Mesgarani, PhD, a principal investigator at Columbia University’s Mortimer B. Zuckerman Mind Brain Behavior Institute. His team recently created a system that translates thought into intelligible, recognizable speech. By monitoring someone’s brain activity, the technology can reconstruct the words a person hears with unprecedented clarity. “We have a potential way to restore that power. We’ve shown that, with the right technology, these people’s thoughts could be decoded and understood by any listener.”

For its part, FDA has committed to searching the landscape for these future innovations with the development of the Emerging Sciences Working Group, a team of 15 FDA experts representing various specialties and FDA Centers. The group is charged with leveraging scientific expertise and resources to conduct long-range horizon scanning and advising agency and FDA Center leadership on how emerging issues and cross-cutting scientific advances may affect the FDA’s preparedness and activities across government agencies, including, says FDA, “asking for public input on advances that aren’t even on most ­people’s radars.”

“Our work on BCI devices also reflects our deep commitment to help the men and women who bravely served our country and were injured, and may suffer from conditions that limit their mobility,” said former FDA commissioner Scott Gottlieb in a statement. “Our duty to serve our veterans includes actively pursuing medical advances that protect and treat them during their service and support them in recovering from injuries. We believe that BCI technology has the potential to improve wounded veterans’ lives and those of other Americans in regaining mobility and thus improving their quality of life.

The draft guidance provides proposed recommendations for developers on what non-clinical testing and clinical study design could be used to develop BCI devices for patients with paralysis or amputation. The agency’s commitment to encourage innovation in these revolutionary areas is great news.

Sherrie Trigg, Editor and Director of Medical Content

To download a copy of the guidance, click here.