FDA Grants Clearance to Bigfoot Unity System, First "Smart" Pen Cap for Insulin Dosing


Bigfoot Medical announced the FDA granted 510(k) clearance to the Bigfoot Unity System for use in patients with type 1 or type 2 diabetes aged 12 years and older.

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The US Food and Drug Administration (FDA) has granted 510(k) clearance to a first-of-its-kind system that could help improve insulin dosing in patients with either type 1 or type 2 diabetes.

Named the Bigfoot Unity Diabetes Management System, the device utilizes a smart pen cap that has the ability to provide on-demand, physician-recommended insulin dose decision support and is designed to be seamlessly integrated with Abbott’s FreeStyle Libre 2 system, according to a statement from Bigfoot Medical.

“For health care providers the Bigfoot Unity diabetes management program could be a gamechanger by connecting them to data that can provide better insight into what their patients are actually doing,” explained diabetologist Jim Malone MD, chief medical officer for Bigfoot Biomedical, in the aforementioned statement. “By replacing guesswork and complexity with connectivity and simplicity, the Bigfoot Unity program is truly serving as that real-time partner for both patients and providers when it comes to dose decision support and overall diabetes management.”

Designed to provide users with a dose recommendation through connection of the system’s smart cap to a person’s insulin pen, the Bigfoot Unity system was created to provide patients with diabetes using multiple daily injection therapy a real-time answer to questions related to insulin dosing. In addition to providing insulin dose decision support, the system also provides users with alerts related to missed doses and incidence of hypoglycemia.

In the statement from Bigfoot Medical, Jared Watkin, of Abbott, noted integrated use of the FreeStyle Libre 2 system with Bigfoot Unity Diabetes Management System could help streamline care for many.

"People with diabetes can be overwhelmed with the amount of data they get from multiple devices, so it's important to develop connected technologies that simplify the experience," said Jared Watkin, senior vice president of Diabetes Care at Abbott. "Through Abbott's collaboration with Bigfoot Biomedical, we're integrating our revolutionary, easy-to-use FreeStyle Libre 2 technology with the Bigfoot Unity System to provide automated information for personalized diabetes management."

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