Search results for "FDA update"
New safety alert for certain continuous glucose monitoring systems
Glucose readers in the FreeStyle Libre product family have the potential for battery swelling and overheating if not properly stored, charged, or used.
https://diabetes.acponline.org/archives/2023/04/14/7.htm
14 Apr 2023
Bionic pancreas cleared for patients with type 1 diabetes
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.
https://diabetes.acponline.org/archives/2023/06/09/8.htm
9 Jun 2023
Insulin pump approved for type 1 diabetes
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.
https://diabetes.acponline.org/archives/2023/05/12/9.htm
12 May 2023
CBT device for type 2 diabetes receives OK to market
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.
https://diabetes.acponline.org/archives/2023/08/11/8.htm
11 Aug 2023
FDA clears marketing of mobile app for automated insulin dosing in type 1 diabetes
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.
https://diabetes.acponline.org/archives/2023/02/10/6.htm
10 Feb 2023
Diabetes device recalled due to risk of fire
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.
https://diabetes.acponline.org/archives/2022/12/09/10.htm
9 Dec 2022
Nearly 1.5 million insulin syringes recalled
Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
https://diabetes.acponline.org/archives/2021/07/09/8.htm
9 Jul 2021
Drug approved to delay onset of stage 3 type 1 diabetes
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.
https://diabetes.acponline.org/archives/2022/12/09/11.htm
9 Dec 2022
Extended-release metformin recalled due to impurity
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.
https://diabetes.acponline.org/archives/2020/06/12/9.htm
12 Jun 2020
Metformin may contain nitrosamine impurity
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.
https://diabetes.acponline.org/archives/2019/12/13/9.htm
13 Dec 2019