"Who else had to do an ' elevated altitude study'..."???
See my previous post. It doesn't MATTER 'who," since the dario is being considered under a 510K application which does NOTHING more than COMPARE the device to ALREADY APPROVED devices.
Moreover, why do a clinical trial for an "altitude study"? That's nonsensical. That requires no more than ONE person going up in a plane and checking readings using control solutions.
It's nothing more than some stupid "penny stock" smoke and mirrors trick -- pap that brokers can use to lure in a few more suckers.