Bigfoot Biomedical announced today that it received FDA 510(k) clearance for the Android version of its Bigfoot Unity mobile app.
Milpitas, California-based Bigfoot received FDA clearance for its diabetes management platform in May 2021. Its initial rollout featured compatibility with iOS devices. The first-of-its-kind system includes connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy.
Bigfoot’s smart pen caps offer on-demand insulin dose decision support. This helps to minimize guesswork and help patients to follow their doctors’ instructions. Additionally, the caps have compatibility with a broad range of disposable insulin pens for both long-acting and rapid-acting insulin.
The mobile app allows users to input and review therapy recommendations from healthcare professionals. Users can also access a glanceable display of their current glucose range and receive real-time alerts.
The company describes the Android version as a “necessary component” of its diabetes management system. According to a news release, 41% of U.S. smartphone users choose Android devices. Once commercially launched, Bigfoot expects the app to be made available via the Google Play Store.
“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,” said Jeffrey Brewer, CEO. “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.”
Today’s announcement marks more big news for the company that sold automated insulin delivery patents to Insulet for $25 million last month.