FDA greenlights Bigfoot Biomedical's insulin recommending diabetes management system
Image: Courtesy of Bigfoot Biomedical This morning, Bigfoot Biomedical announced it has received FDA 510(k) clearance for its Bigfoot Unity Diabetes Management System. The system was cleared for use among individuals 12 years old and up with Type 1 or Type 2 diabetes who use multiple-dose injection therapy. Included in the Bigfoot Unity System are two smartpen caps for both rapid- and long-acting insulin, a connected mobile app, an integrated FreeStyle Libre 2 Sensor from Abbott and a blood glucose meter. What sets Bigfoot’s system apart is the smartpen caps that take data from the FreeSty...