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Bigfoot Biomedical receives clearance for smart insulin pen cap system 

May 13, 2021HME News Staff

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...

Bigfoot Biomedical, Diabetes, Smart Insulin Pen

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