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Thought-Controlled Prosthetics Get US FDA 'Leapfrog' Treatment

 
• By David Filmore

A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit for pre-submissions meetings and investigational device exemptions.

3D X-ray of human brain with computer chip and circuit on star and galaxy background - Illustration

US FDA has been working with academic scientists, the US military and device companies for the past decade on implants that might interface with the nervous system, allowing a paralyzed patient or amputee to control a prosthetic with their thoughts. The agency recorded what it has learned from those efforts in a draft guidance posted Feb. 22 that is intended to help sponsors develop such a device to the point of entering clinical studies.

FDA's interest in the advancing field of brain-computer interface (BCI) devices has been evident at least since 2011, when it...

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