> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Tidepool Loop Insulin Dosing App Cleared
- URL: https://www.fdaweb.com/tidepool-loop-insulin-dosing-app-cleared/
- Published: 2023-01-24T12:00:00.000Z
- Updated: 2026-09-14T18:12:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153613

FDA has cleared a Tidepool 510(k) for its Tidepool Loop, an automated insulin dosing app intended for managing Type 1 diabetes in patients aged six years and older. Tidepool Loop is described by the company as a patient-led project that allows insulin delivery from a compatible Apple Watch. “The algorithm technology in Tidepool Loop is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values,” it says. The device can also deliver correction boluses when glucose values are predicted to exceed predefined thresholds.