On Feb. 8, The Food & Drug Administration unveiled a new, fast-track protocol for breakthrough medical technologies this week, saying its new "Innovation Pathway" aims to speed high-tech devices to market.
Projects tapped for the innovation program would have to be "truly pioneering" and capable of "revolutionizing patient care or healthcare delivery" to be eligible. Those tapped would receive roadmap and timeline from the Center for Devices & Radiological Health (CDRH) for the development, testing and review of the device. An FDA "case manager" would be assigned to each project, to help identify and address "important scientific issues" early on.
The HandTutor system measures isolated and coordinated finger and wrist movement. The dedicated rehabilitation software allows for movement guidance to show the patient how to move their hand or prosthetic and augmented feedback to show that the prosthetic is moving. A combination of guidance and visual augmented feedback allows for learning motor movement.
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