Thought-Controlled Prosthetics Get US FDA 'Leapfrog' Treatment
A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit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.
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The technology could allow people with paralysis to operate computer-controlled prosthetic limbs and other devices with their thoughts.
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Brain-computer interface device makers should consider customer accessibility and clinicians’ ability to deploy the BCI system to get to market, Medtronic technology director says at an FDA meeting. New brain-machine interface include products to help paraplegics walk and people with tremors to grasp tools used in daily life.