Bigfoot Biomedical’s Diabetes Management Platform Cleared

The FDA has granted Bigfoot Medical 510(k) clearance for its Unity Diabetes Management System, a product that gives insulin dose recommendations for patients on multiple daily injection therapy.

The system features smart pen caps that deliver on-demand insulin dosing. Compatible with all major disposable insulin pens, the smart pen caps connect with Abbott’s FreeStyle Libre 2 system to obtain continuous glucose monitoring system data.

The recommended dose is displayed directly on a connected smart cap without the need for manual entry of glucose data on a separate device.