Brain-Managed Robot Arm Kicks Off New FDA Program To Hurry Up Approval Of Medical Devices

Update: A tipster has identified that the robotic arm in query, and seen briefly within the video after the break, is definitely the Modular Prosthetic Limb developed by Johns Hopkins University’s Applied Physics Laboratory (now pictured above), not Deka’s Luke arm. SILVER SPRING, Md., Feb. 8, 2011 /PRNewswire-USNewswire/ –Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a precedence overview program for brand spanking new, breakthrough medical units and introduced the first submission: a brain-managed, upper-extremity prosthetic that can function a pilot for this system. The FDA also announced plans to seek further public comment before the Pathway can be utilized more broadly. The initiative may even seek to strengthen the nation’s research infrastructure for creating breakthrough applied sciences and advancing high quality regulatory science. In addition, CDRH intends to engage in formal horizon scanning – monitoring medical literature and scientific funding in a systematic approach to predict the place technology is heading. CDRH will embrace public enter in this process to prepare for and respond to transformative innovative applied sciences and scientific breakthroughs.

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