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The FDA cleared the Bigfoot Unity diabetes management system, used in conjunction with Abbott s FreeStyle Libre 2 system, for type 1 and 2 diabetes; the system translates continuously monitored glucose data into on-demand insulin dosing recommendations shown on the pen-cap screen.
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FDA Clears Cap Device for Smart Insulin Pens for Diabetes
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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.
May 10th, 2021
Bigfoot Biomedical
The Food and Drug Administration has rubber-stamped a smart cap system for insulin pens. Bigfoot Unity works with an integrated continuous glucose monitoring system (iCGM) to provide recommendations for insulin doses. According to Bigfoot Biomedical, it s the only FDA-cleared dose decision support system with real-time hypoglycemia alerts and it can help patients minimize the guesswork for how much insulin they need.
For now, Bigfoot Unity only supports Abbott s FreeStyle Libre 2, one of the two major iCGMs alongside Dexcom. It s designed for people with Type 1 or Type 2 diabetes who are using multiple daily injection (MDI) therapy. The connected smart cap displays the recommended dose, along with the patient s glucose value and trend arrow, without them having to manually enter their blood sugar data on a separate device.
Author Bio
A Fool since 2019, Prosper s writing focuses primarily on the healthcare sector. Passionate about teaching and learning, he enjoys helping others make better decisions about their finances and enjoys it just as much when they return the favor. In his free time, you ll find him curling up with a good book or doing math.
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