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or (2) for devices for which pass-through status will begin on or after January 1, 2020, as an alternative to the substantial clinical improvement criterion, the device is part of the FDA's Breakthrough Devices Program and has received FDA marketing authorization for the indication covered by the Breakthrough Device designation

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Glucose Signaling and Endocrine Pathways AOD 9604 has been investigated in laboratory models assessing glucose metabolism and endocrine signaling