www.fdanews.com/articles/200808-tidepool-finalizes-fda-submission-for-insulin-dosing-app
Tidepool Finalizes FDA Submission for Insulin-Dosing App
January 11, 2021
Tidepool, a nonprofit organization founded by diabetics, caregivers and healthcare providers, announced that it has completed its marketing submission to the FDA for the Tidepool Loop, an automated insulin-dosing app designed to help manage type 1 diabetes.
The agency has now begun the substantive review of the product, which could become the first Apple iOS app for automatic insulin dosing if cleared.
Tidepool anticipates that the app, which can connect to a variety of insulin pumps and continuous glucose monitoring systems, should be available later this year.