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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.
Novo Nordisk issued a nationwide voluntary recall of several batches of its insulin product samples Levemir, Tresiba, Fiasp, Novolog, and Xultophy due to improper temperature storage.
Not only has 2.4 mg of injectable semaglutide demonstrated efficacy for weight loss, but it also may help dampen appetite, food cravings, and calorie intake, according to a study presented at the European Congress on Obesity. (
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.
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 physician. Bigfoo