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I had the privilege of seeing Dean Kamen speak last year about the DEKA arm. One of the things he lamented was that the FDA had to decided not to classify the arm as Class I, and as such it was getting caught up in drawn out regulation when there were people he felt it could help right now.

Video demo of the updated, 3rd-generation DEKA arm. http://youtu.be/auetIxOaSe8

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Thanks for the link. The DEKA arm is a great piece of tech.

I could speculate that because it relies on new tech and new research into prosthetic devices that the didn't just rubber stamp it.

Part of what the FDA does is safety, and the other part is validating the claims that a device or drug manufacturer makes. It's probably for this reason that they imposed additional regulatory validation. Because a cyborg arm? That HAS to be SCI-FI, right? ;)

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