FDA Clears Cap Device for Smart Insulin Pens for Diabetes medscape.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medscape.com Daily Mail and Mail on Sunday newspapers.
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 FreeStyle Libre 2 continuous glucose monitor to give users insulin dose recommendations based on a physician’s instructions. To use the smartpen cap for rapid-acting insulin, users scan the FreeStyle Libre 2 sensor and the pen cap displays their current glucose value as well as any recommended correction doses.