Bigfoot Biomedical receives clearance for smart insulin pen cap system 

MILPITAS, Calif. – Bigfoot Biomedical has received 510(k) clearance from the U.S. Food and Drug Administration for its Bigfoot Unity Diabetes Management System, which features connected smart pen caps that recommend insulin doses for people using multiple daily injections. “Diabetes management is incredibly hard because insulin has no fixed dose or timing, leaving individuals to constantly determine their doses and configure devices as they make multiple critical decisions every day about how much insulin to take,” said Jeffrey Brewer, CEO. “At Bigfoot, we want to ease the burden of diabetes for people taking insulin by minimizing the anxious guesswork involved with insulin dosing in a convenient, simple way.” The Bigfoot Unity System is the first and only solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly uses integrated continuous glucose monitoring system data from Abbott’s FreeStyle Libre 2 system to provide an insulin dose recommendation. The system is compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens, including those by Eli Lilly and Company, Novo Nordisk and Sanofi.