Search results for "FDA update"

Results 1 - 10 of about 84 for "FDA update".
Sort by: Relevance | Newest | Oldest

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.
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.
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.
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.
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.
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.
9 Dec 2022

Nearly 1.5 million insulin syringes recalled

Recalled syringes may have graduated markings that are printed incorrectly on the syringe barrel.
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.
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.
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.
13 Dec 2019

Result Page: Prev   1   2   3   4   5   6   7   8   9   Next