Bigfoot Biomedical today announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices, this clearance enables expanded 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,” says Jeffrey Brewer, CEO of Bigfoot Biomedical. “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.”
The Bigfoot Unity System is the 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. The system features smart pen caps compatible with a broad range of disposable insulin pens for both long-acting and rapid-acting insulin. The Bigfoot Unity Mobile App allows users to input and review healthcare professional therapy recommendations, provides a glanceable display of current glucose range, and delivers important real-time alerts. The holistic approach aims to simplify the complexities of diabetes management, so people on multiple daily injection therapy can focus on what matters most in their lives.
Once commercially launched, the Android phone application will be available via the Google Play Store.