Glucose readers in the FreeStyle Libre product family have the potential for battery swelling and overheating if not properly stored, charged, or used.
14 Apr 2023
The new automated insulin dosing system, called the iLet Bionic Pancreas, is intended for use in patients ages 6 years and older with type 1 diabetes.
9 Jun 2023
The FDA recently approved the MiniMed 780G System for continuous delivery of basal insulin at selectable rates and the administration of insulin boluses at a selectable amount for the management of type 1 diabetes in patients ages 7 years and older requiring insulin.
12 May 2023
The FDA recently authorized marketing of a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes.
11 Aug 2023
The prescription-only mobile application is intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older.
10 Feb 2023
The FDA recently announced a class I recall of the Omnipod DASH Insulin Management System Personal Diabetes Manager due to reports of battery issues, including battery swelling, fluid leakage, and extreme overheating that may pose a fire hazard.
9 Dec 2022
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
9 Jul 2021
The first-in-class therapy, indicated in adults and pediatric patients ages 8 years and older who currently have stage 2 type 1 diabetes, is administered by IV infusion once daily for 14 consecutive days.
9 Dec 2022
After recommending that several manufacturers recall the diabetes drug due to excess levels of N-nitrosodimethylamine, the FDA is assessing whether the recalls will result in shortages.
12 Jun 2020
The FDA is investigating whether metformin in the U.S. market contains N-nitrosodimethylamine. Low levels of the impurity have been found in the drug in other countries; however, there are no U.S. recalls at this time.
13 Dec 2019