"...NIH-Funded Trials", does this have to with the delay..."????
Wellllllll...since it's NOT an NIH funded trial bur a DRIO SHAREHOLDER funded trial, I wouls be inclined to think NOT.
Moreover, WHY did they do an "altitude study"? The dario uses one of the same methodologies that all other glucometers use. Since the FDA application ONLY compares the dario to those devices that are ALREADY approved, one MIGHT rationally presume that altitude effects are ALREADY understood.
For that matter, why waste time, effort, and money doing ANY trials at ALL? A 510K application does NOT require ANY clinical trial since ALL it does is compare the device to other ALREADY approved devices.