Tuesday, November 27, 2018 3:52:40 PM
Seems hard to fathom that they can lose the approval while winning the innovation challenge, but I'm sure it's a different analysis and people involved...
It would be truly Karmic if another division in the FDA grants access to the innovation challenge, while quickly throwing mud on the face of the 510K panel that rejected the Actipatch. In this scenario the media might actually start asking pointed questions about why this technology isn't being used more extensively in the US.
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