Yesterday Tidepool announced that finally at long last they have submitted their app to the FDA. Per a company issued press release
“Tidepool, a 501(c)3 nonprofit, today announced completion of its FDA submission of Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes.
The nonprofit was notified on December 22, 2020, that the submission had completed FDA’s administrative acceptance review and was proceeding to substantive review as an interoperable automated glycemic controller (iAGC). If cleared, Tidepool Loop could become the first app for iOS cleared for the automatic dosing of insulin . . .
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