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Bigfoot Biomedical gets FDA clearance for 'smart' insulin pen caps

MedCity News
Bigfoot Biomedical gets FDA clearance for ‘smart’ insulin pen caps
The startup received 510(k) clearance for its “smart” insulin pen cap, which pulls in data from users’ connected glucose monitor to help them calculate the right dose.
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Bigfoot Biomedical received FDA clearance for its smart pen system. Photo credit: Bigfoot Biomedical
In a significant step forward, Bigfoot Biomedical got the greenlight from the Food and Drug Administration for its “smart” insulin pen cap, developed to be paired with a continuous glucose monitor.
It received 510(k) clearance for use among individuals ages 12 and up with Type 1 or Type 2 diabetes who use multiple-dose injection therapy. ....

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FDA Clears Cap Device for 'Smart' Insulin Pens for Diabetes

FDA Clears Cap Device for 'Smart' Insulin Pens for Diabetes
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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 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. ....

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The FDA Just Approved This Smart Insulin Pen Cap

Image: Bigfoot Biomedical
The Food and Drug Administration has granted approval for an innovative smart pen cap system to help those with both Type 1 and Type 2 diabetes better manage their insulin dosage. This is huge news, as the system could help diabetics eliminate the guesswork when it comes to figuring out how much insulin to take, using real-time data.
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The Bigfoot Unity smart pen caps are made by Bigfoot Biomedical and are meant to be used by patients undergoing multiple daily injection therapy. The smart pen caps received 510 (k) clearance from the FDA, and according to the company, it’s the first system of its kind. It works in tandem with the Abbott FreeStyle Libre 2 integrated continuous glucose monitoring system (iCGM) to provide real-time blood glucose data. The user scans the sensor, and the cap then displays a patient’s blood sugar, a trend arrow, and a suggested dosage based on those values and what’s been recommended by their physic ....

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