Bigfoot Biomedical’s Bigfoot Unity Android App OK’ed

Bigfoot Biomedical has been issued U.S. Food and Drug Administration (FDA) 510(k) clearance for the Android version of its Bigfoot Unity mobile app, a component of the Bigfoot Unity diabetes management system.
 
41% of U.S. customers choose Android devices, so this clearance expands access to a large group of people with diabetes. Bigfoot Unity has been compatible with iOS devices since May 2021.
 
“Most Bigfoot Unity users live with type 2 diabetes and are part of a demographic that is even more likely to use Android devices than the general U.S. population,” Jeffrey Brewer, CEO of Bigfoot Biomedical told the press. “Therefore, as we prepare for our enhanced commercial rollout later this year, this clearance is key to enabling us to expand access to our comprehensive and easy-to-use solution and deliver on our goal to minimize the anxious guesswork involved with insulin dosing.”
 
Bigfoot Unity is an FDA-cleared smart injection system that turns continuous glucose management data into insulin dosing advice displayed on the pen cap for those taking multiple daily injections. The system features smart pen caps compatible with a range of disposable insulin pens for both long-acting and rapid insulin.
 
The Bigfoot Unity mobile app lets users input and review healthcare professional recommendations, provides a display of current glucose range, and sends real-time alerts.
 
Once launched, the Android app will be available on the Google Play Store.