Search results for "FDA update"
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
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
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
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
Alert warns about cybersecurity risk with insulin pump system
A potential issue with the Medtronic MiniMed 600 Series Insulin Pump System's communication protocol could allow unauthorized access to the device, the FDA said.
https://diabetes.acponline.org/archives/2022/10/14/9.htm
14 Oct 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
More metformin recalled due to nitrosamine impurity
The recall includes 33 lots of metformin hydrochloride extended-release tablets USP (750 mg) manufactured in India and distributed in the U.S.
https://diabetes.acponline.org/archives/2022/01/14/6.htm
14 Jan 2022
Insulin recalled due to potential missing label
Mylan Pharmaceuticals Inc. is recalling one batch of insulin glargine injection due to the potential for a missing label on some pens within a labeled carton.
https://diabetes.acponline.org/archives/2022/02/11/6.htm
11 Feb 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