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Military Has First Dibs On New FDA Path With Brain-Controlled Prosthetic

This article was originally published in The Gray Sheet

Executive Summary

While CDRH's innovation initiative is technically in the proposal stage and subject to public comment, the center is moving forward with a pilot run of the new priority-review program.

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A new "leapfrog" draft guidance from the US agency addresses implanted brain-computer interface prosthetic devices, and, specifically, the information sponsors should be prepared to submit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

FDA Approves Advanced Prosthetic Arm

FDA approved an advanced prosthetic arm from Deka R&D Corp. May 9 that has the ability to translate electrical signals from muscle into complex tasks.

Research In Brief

New obesity device pivotal study and more research news.

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