Android app compatible with smart cap for insulin pens receives FDA clearance
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The FDA has granted 510(k) clearance for the launch of an Android mobile app for a connected smart cap for insulin pens, according to an industry press release.
As Healio previously reported, The Bigfoot Unity diabetes management system (Bigfoot Biomedical) was granted 510(k) clearance by the FDA in May 2021 for use by people with diabetes prescribed multiple daily insulin injection therapy. When the system was originally cleared, it was compatible with iOS devices only. This new approval will allow the system to be used by people with Android devices, opening up its use to the 41% of the U.S. population who use those types of devices, according to the press release.
“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, said in a press release. “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 diabetes management system is comprised of smart caps that are integrated with the user’s continuous glucose monitor. The system uses CGM data to display insulin dosing advice on the pen cap for the user. The smart pen caps are compatible with a range of disposable insulin pens for long-active and rapid-acting insulin. The mobile app allows users to input and review health care provider therapy recommendations, look at their current glucose range and receive real-time alerts.
Once it is launched, the Android application will be available for download at the Google Play store.
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