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# FDA Clears Bigfoot Bio Android Diabetes App
- URL: https://www.fdaweb.com/fda-clears-bigfoot-bio-android-diabetes-app/
- Published: 2023-03-02T12:00:00.000Z
- Updated: 2026-09-14T18:17:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153892

FDA has cleared a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Management System. Because 41% of U.S. smartphone users choose Android devices, the clearance is intended to enable expanded access to those with diabetes, according to the company. Bigfoot Unity has been cleared for use on Apple (iOS) devices since 5/2021.

“The Bigfoot Unity System is the first and only FDA-cleared smart injection system that turns continuous glucose management (CGM) data into insulin dosing advice displayed right on the pen cap for people using multiple daily injection therapy,” according to the company. The device features smart pen caps that are compatible with a broad range of disposable insulin pens for both long-acting and rapid-acting insulin. The app permits users to input and review physician-directed therapy recommendations, view current glucose range and important real-time alerts, the company says.